Sotrovimab (Xevudy) Anti-SARS-CoV-2 Antibody Description For 2022
GSK and Vir Biotechnology's Sotrovimab (Xevudy®) (VIR-7831, GSK4182136, S309) is a pan-sarbecovirus anti-SARS-CoV-2, human neutralizing monoclonal antibody (mAbs) selected based on its ability to neutralize the beta coronavirus in vitro, kill infected cells, and provide a high barrier to infection. Sotrovimab was derived from a parent antibody (S309), first isolated in 2003 from an individual's memory B cells recovered from a SARS-1 coronavirus infection. Neutralizing mAbs act like human antibodies in the immune system.
Sotrovimab is a biological medicine (synthetic) that binds to an epitope on the SARS-CoV-2 coronavirus. Sotrovimab demonstrated the ability to neutralize SARS-CoV-2 infections, indicating that the epitope is highly conserved, making it more difficult for escape virus mutants to develop. Sotrovimab incorporates Xencor, Inc.'s Xtend™ technology, designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.
In April 2020, Vir Biotechnology, Inc. and GlaxoSmithKline LLC (GSK) announced a collaboration to research and developed Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new antiviral antibodies. On May 26, 2021, GSK received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) sotrovimab and by the U.K.'s NHS on December 20, 2021.
In December 2021, the FDA updated the EUA, allowing healthcare providers to administer sotrovimab to treat mild to moderate COVID-19 patients 12 years of age and older weighing at least 40 kg with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization. The Companies requested authorization to include intramuscular administration on January 13, 2022. And on March 25, 2022, the FDA limited the use of Sotrovimab to treat COVID-19 in some U.S. regions due to the dominance of the BA.2 Omicron sub-variant.
On March 14, 2022, the JAMA Network published results from an Original Investigation of a randomized phase 2/3 clinical trial of 1,057 participants, treatment with a single intravenous dose of sotrovimab, compared with placebo, resulted in a statistically significant reduction in the proportion of patients who experienced a composite outcome of all-cause hospitalization lasting longer than 24 hours or death through day 29 (1% vs 6%, respectively; adjusted relative risk, 0.21). The Microbiology/Resistance Information, Antiviral Resistance (Section 15): addition of information on the susceptibility of SARS-CoV-2 variants to sotrovimab was revied in the March 2022 Fact Sheet.
On May 27, 2022, the peer-review journal The Lancet published a Correspondence that stated, 'Immunocompromised patients treated with monoclonal antibodies should benefit from a reinforced virological follow-up, including viral sequencing and viral load assessment.'
On June 8, 2022, the EMA published a list of critical authorized medicines for the COVID-19 public health emergency. The FDA Letter of Authorisation. CAS Number: 2423014-07-5; Drugbank: DB16355; UNII: 1MTK0BPN8V; KEGG: D12014; ATC code: J06BD.
Vir Biotechnology, Inc. (Nasdaq: VIR) is a California-based clinical-stage immunology company that combines immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.
GSK is a science-led global healthcare company. For further information, please visit www.gsk.com/about-us. Early VIR - GSK clinical studies received funding support through the U.S. Operation Warp Speed.
Sotrovimab Omicron BA.x sublineages
As of July 21, 2022, the U.S. NIH OpenData Portal reported Sotrovimab's effectiveness against the Omicron virus variant. And on July 20, 2022, the NEJM published a Correspondence - Efficacy of Antibodies and Antiviral Drugs against Omicron BA.2.12.1, BA.4, and BA.5 Subvariants: Our findings show that the selection of monoclonal antibodies to treat patients who are infected with omicron variants should be carefully considered. And a study published by the journal Nature on Mar. 3, 2022, found Sotrovimab retained appreciable activity against BA.1 and BA.1+R346K.
As of August 1, 2022, Sotrovimab (Xevudy) had been granted authorization in Australia, Bahrain, Brazil, Cyprus, Ireland, France, Saudi Arabia, Europe, Japan, Egypt, Italy, Kuwait, Oman, Qatar, Singapore, Switzerland, Thailand, the United Arab Emirates, and by the WHO conditionally recommended the mAbs. Canada issued Approval on July 30, 2021, and the UK's MHRA approved Xevudy (sotrovimab) on Dec. 2, 2021. The European Medicines Agency (EMA) and the European Commission authorized Xevudy (Sotrovimab) on December 17, 2021. And the WHO gave an authorization update for treating mild or moderate COVID-19 in patients at high risk of hospitalization on January 14, 2022.
GSK confirmed on February 9, 2022, that it had received binding agreements to sell approximately 1.7 million Xevudy doses worldwide, including a portion of those procured by the US Government. Sotrovimab is not commercially available for retail purchase in the U.S. as of July 2022.
Find information on the availability and ordering of sotrovimab by visiting GSK's website.
Springer published on March 14, 2022, Sotrovimab: First Approval. A phase 2/3 clinical study was launched on September 10, 2020, in which subjects with COVID-19 will receive VIR-7831 or placebo and be assessed for safety, tolerability, efficacy, and pharmacokinetics. Initial Phase 3 results may be available as early as the end of 2020; results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021. A manuscript developed by Vir in collaboration with the MRC-University of Glasgow Centre for Virus Research, published on November 5, 2020, "shows that the receptor-binding motif of SARS-CoV-2, a major target of neutralizing antibodies, is evolving at a higher rate than the rest of the receptor-binding domain and spike, and is resilient to change," said Herbert "Skip" Virgin, MD, Ph.D., chief scientific officer of Vir, in a press release.
On December 17, 2020, the US NIH stated, 'One sub-study evaluates VIR-7831 Antibodies are infection-fighting proteins naturally made by the immune system Antibodies can prevent viruses from infecting cells, sometimes binding to the viruses' surface Synthetic versions of these antibodies, prepared in a laboratory, are known as monoclonal antibodies.'
On March 3, 2021, the companies were informed that while VIR-7831 met initial pre-specified criteria to continue to the next phase of the ACTIV-3 trial and there were no reported safety signals, sensitivity analyses were available data raised concerns about the magnitude of potential benefit. As a result, the independent Data and Safety Monitoring Board has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature. And the NEJM published an ORIGINAL ARTICLE on November 8, 2021: Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab - Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression.
The NEJM published an ORIGINAL ARTICLE on November 18, 2021: Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. The phase 2/3 study conclusion stated, 'Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression, and no safety signals were identified.' The Phase 3, randomized, open-label, non-inferiority COMET-TAIL clinical trial, which achieved its primary endpoint, demonstrated that 500 mg IM administration of sotrovimab (n=376) was non-inferior and offered similar efficacy to 500 mg IV administration (n=378) for the early treatment of mild-to-moderate COVID-19 in high-risk, nonhospitalized adults and adolescents. In addition, low rates of serious adverse events (≤1% in both arms) were observed in the headline data.
On January 14, 2022, the WHO Listed sotrovimab for treating mild or moderate COVID-19 in patients at high risk of hospitalization. In B.C. Canada, the COVID-19 Treatment Self-Assessment tool was updated on Jan. 25, 2022. There is a potential risk of treatment failure due to the development of viral variants that are resistant to sotrovimab. Prescribing healthcare providers should choose an authorized therapeutic option with activity against circulating SARS-CoV-2 variants in their state. SARS-CoV-2 variant frequency data for states and jurisdictions can be accessed on the CDC website. When using Anti-SARS-CoV-2 monoclonal antibodies, treatment should be started as soon as possible after the patient receives a positive result on a SARS-CoV-2 antigen or nucleic acid amplification test (NAAT) and within ten days of symptom onset. Authorized by the US FDA, the benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID‑19 In addition, SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID‑19 requiring high flow oxygen or mechanical ventilation.
And the U.S. FDA says 'Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19, and authorization of sotrovimab under the EUA is not limited to the medical conditions or factors listed above.'
The SARS-CoV-2 genome encodes four major structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N), as well as nonstructural and accessory proteins. The spike protein is further divided into S1 and S2, which mediate host cell attachment and invasion. Through its receptor-binding domain (RBD), S1 attaches to angiotensin-converting enzyme 2 (ACE2) on the host cell; this initiates a conformational change in S2 that results in virus-host cell membrane fusion and viral entry.
Sotrovimab Side Effects
The safety profile of Xevudy was favorable, with a small number of hypersensitivity (allergic) reactions and infusion-related reactions, and the EMA's CHMP concluded that the medicine's benefits are greater than its risks for the approved use. The FDA says SARS-CoV-2 mAbs may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
Adverse reactions: Diarrhea, hypersensitivity reactions (including rash, dermatitis contact, skin reaction, hypersensitivity, multiple allergies, infusion-related reaction, and bronchospasm). One case of anaphylaxis was reported following an infusion of sotrovimab in a study in hospitalized patients; the patient received epinephrine, and the event resolved.
Clinical worsening of COVID‑19 after SARS-CoV-2 monoclonal antibody treatment has been reported. It may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. However, it is unknown if these events were related to SARS-CoV-2 monoclonal antibody use or were due to the progression of COVID‑19. Contraindications: Hypersensitivity to the active substance or any of the excipients. Interactions: No formal interaction studies have been performed. The efficacy and safety of sotrovimab in subjects who have received a COVID-19 vaccine before its administration have not been established. Receiving a COVID-19 vaccine within 48 hours or four weeks following treatment with XEVUDY has not been studied.
Sotrovimab Payment in the U.S.
During the COVID-19 public health emergency, Medicare pays for mAbs infusions (when furnished consistent with their respective EUAs) the same way it covers and pays for COVID-19 vaccines. CMS identified specific code(s) for each COVID-19 monoclonal antibody product and a particular administration code (Q0247) for Medicare payment.
Sotrovimab Financial News
Sales of Xevudy were £466 million in the second quart of 2022, with the overwhelming majority of sales achieved in Europe £123 million and International £320 million. In the US, the government contract was completed in Q1 2022.
April 27, 2022 - GSK reported sales of Xevudy were £1,307 million and contributed 25 percentage points of growth in the quarter. Xevudy sales were delivered in all regions, comprising the US £770 million, Europe £311 million, and International £226 million.
February 9, 2022 - GSK reported sales of Xevudy were £958 million in the year. In the US, reported sales were £602 million. International recorded sales of £287 million and Europe £69 million. Xevudy generated sales of £828 million ($1.12 billion) during the fourth quarter, compared with £114 million in the third quarter. Sales were majorly driven by U.S. government contracts aggregating to £586 million during the reported quarter. Xevudy sales contributed 6% to GSK's pharmaceutical sales growth.
August 1, 2022 -The JAMA Network published a Research Letter: Development of Resistance-Associated Mutations After Sotrovimab Administration in High-risk Individuals Infected With the SARS-CoV-2 Omicron Variant. This small study found rapid development of sotrovimab resistance-associated mutations at positions S:E340 and S:P337 in high-risk patients infected with the Omicron variant after treatment with sotrovimab.
July 25, 2022 - The journal Nature published a study: Patient-derived monoclonal antibody neutralizes SARS-CoV-2 Omicron variants and confers full protection in monkeys. ' We conclude that this combination of mAbs has potential as an anti-Omicron drug.'
June 29, 2022 - The journal Nature published an article: Antibodies will be a key solution for the next pandemic, adds Julie Gerberding, chief executive of the Foundation for the National Institutes of Health in Bethesda, Maryland, and former director of the US CDC. "The idea of using antibodies to ward off new infectious diseases is just — to me — common sense."
June 21, 2022 - PW reported: that Sotrovimab reduces the severity of COVID-19 progression and was not associated with significant adverse events in high-risk patients with mild-to-moderate COVID-19.
May 23, 2022 - A non-peer-review study concluded: In routine care of non-hospitalized high-risk adult patients with COVID-19 in England, those who received sotrovimab were at lower risk of severe COVID-19 outcomes than those receiving molnupiravir.
May 3, 2022 - UK medicines regulators are reviewing emerging clinical evidence that sotrovimab may not be as effective against the current dominant strain of SARS-CoV-2. So far more than 18,000 patients in the UK have received sotrovimab.
April 14, 2022 - Health Canada issued: Sotrovimab for Injection - Risk of Treatment Failure due to Circulation of SARS-CoV-2 Omicron BA.2 Subvariant.
March 30, 2022 - The U.S. FDA announced additional limits on using Sotrovimab to treat COVID-19 in certain U.S. regions due to the BA.2 Omicron sub-variant dominance.
March 25, 2022 - HHS/ASPR announced the U.S. CDC Data Tracker had identified that the coronavirus subvariant BA.2 variant is now circulating with a frequency exceeding 50% in HHS Region 1 (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont) and Region 2 (New Jersey, New York, Puerto Rico, and the Virgin Islands). Results from in vitro assays used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that sotrovimab is not fully active against the BA.2 variant.
March 14, 2022 - The JAMA Network published an Original Investigation: Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19. Findings In this randomized clinical trial of 1057 participants, treatment with a single intravenous dose of sotrovimab, compared with placebo, resulted in a statistically significant reduction in the proportion of patients who experienced a composite outcome of all-cause hospitalization lasting longer than 24 hours or death through day 29 (1% vs. 6%, respectively; adjusted relative risk, 0.21).
March 9, 2022 - The NEJM published a Correspondence: Resistance Mutations in SARS-CoV-2 Delta Variant after Sotrovimab Use. These data show the persistence of viable SARS-CoV-2 in patients after sotrovimab infusions and the rapid development of spike gene mutations associated with high-level sotrovimab resistance in vitro. Genomic analysis showed that 4 of these 8 patients acquired previously defined receptor-binding domain mutations within 6 to 13 days after they received sotrovimab. Mutations in S:E340 developed in all 4 patients.
March 9, 2022 - Ireland media reported there is some concern that sotrovimab is less effective against Omicron, but it does currently appear to retain the ability to fend off the worst effects of the coronavirus.
February 15, 2022 - Wiley Clinical Healthcare Hub published - Most trials have shown they (mAbs) are effective in reducing the risk of hospital admission and severe disease in people with mild to moderate COVID-19.
February 9, 2022 - Vir Bio issued a press statement: George Scangos, Vir's CEO, commented, "We note recent conclusions from another lab. We are therefore pleased to share that, based on our pseudovirus and extensive pharmacokinetic data, we believe that the 500 mg dose of sotrovimab is sufficient to retain activity against the BA.2 variant, just as it has against all other variants of concern and interest."
February 4, 2022 - According to what the Deputy Director of Pharmaceutical Services of the Ministry of Health, Dr. Elena Panayotopoulou, told Kathimerini, the "Xevudy" monoclonal received the "green" light from the European Medicines Agency.
January 24, 2022 - The U.S. FDA's Patrizia Cavazzoni, M.D., Director - Center for Drug Evaluation and Research, confirmed Sotrovimab's available in the U.S.
January 22, 2022 - Although sotrovimab is produced in Italy, only 1,542 doses have been administered, according to the Italian Medicines Agency update on January 13, 2022.
January 22, 2022 - The WSJ reported GSK and Vir Biotechnology are increasing output at a second plant to help meet the demand for sotrovimab. The U.S. FDA on Dec. 30, 2021, cleared a Samsung Biologics site as a second manufacturing facility to make Xevudy (sotrovimab), a GSK spokesperson told Fierce Pharma. GSK and Vir have said they expect to manufacture about 2 million doses globally in the first half of 2022.
January 19, 2022 - The Lancet published the results from a study that confirmed Sotrovimab (Xevudy) was effective against the Omicron SARS-CoV-2 B.1.1.529 variant of concern.
January 19, 2022 - The U.S. NIH published updated mAbs treatment guidelines.
January 17, 2022 - The U.S. government confirmed new state, territory, and agency-based allocations of Sotrovimab for this week.
January 14, 2022 - The WHO panel of experts conditionally recommended the use of sotrovimab for treating mild or moderate COVID-19 in patients who are at high risk of hospitalization. This includes patients who are older, immunocompromised, have underlying conditions like diabetes, hypertension, and obesity, and those unvaccinated.
January 13, 2022 - GSK and Vir Biotechnology, Inc. announced the submission of an application to the U.S. FDA requesting an amendment to the Emergency Use Authorization (EUA) for sotrovimab including intramuscular administration (500 mg). The EUA for sotrovimab was granted by the FDA in May 2021 as an investigational single-dose intravenous (500 mg) infusion SARS-CoV-2 monoclonal antibody for the early treatment of COVID-19.
January 11, 2022 - GSK and Vir Biotechnology, Inc. announced that the US Government will purchase an additional 600,000 doses of sotrovimab.
January 6, 2022 - GSK Canada announced it has signed agreements with the Government of Canada to supply 20,000 doses of Sotrovimab for injection. This order follows an initial purchase agreement to supply 10,000 doses of Sotrovimab, announced on October 4, 2021.
January 5, 2022 - Ireland's Health Minister Stephen Donnelly brought a memo to Cabinet proposing the Government expand ordering new COVID-19 treatments. Ireland is already part of an EU agreement for the purchase of the GSK monoclonal antibody product Xevudy (Sotrovimab).
January 2, 2022 - Sotrovimab was approved for use by Health Canada in July 2021. To date, Canada has received 10,000 doses of sotrovimab from Italy, Public Services and Procurement Canada told Global News.
December 31, 2021 - Vir Biotechnology, Inc. announced new non-peer-reviewed preclinical research describing the structural basis and magnitude of the new SARS-CoV-2 Omicron variant (B.1.1.529) may evade antibody-mediated immunity, as well as its enhanced ability to bind to the human ACE-2 receptor.
December 27, 2021 - The State of Texas announced its regional infusion centers had exhausted their supply of sotrovimab, the monoclonal antibody effective against the COVID-19 Omicron variant, due to the national shortage from the federal government.
December 23, 2021 - The Texas Department of State Health Services confirmed the Amarillo Area Infusion Center would begin providing Sotrovimab on Dec. 24, 2021.
December 20, 2021 - The UK announced the Sotrovimab monoclonal antibody would be given as a transfusion to transplant recipients, cancer patients, and other high-risk groups.
December 17, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced that the European Commission had granted marketing authorization to Xevudy (sotrovimab) for the early treatment of COVID-19.
December 16, 2021 - The EMA's vaccine committee has recommended authorizing the monoclonal antibody Xevudy (sotrovimab) for the treatment of COVID-19 for certain people. In reaching its conclusion, the CHMP evaluated data from a study involving 1,057 patients with COVID-19 showing that treatment with Xevudy significantly reduces hospitalization and deaths in patients with at least one underlying condition putting them at risk of severe COVID-19. Following treatment with Xevudy, 1% of patients (6 out 528) were hospitalized for longer than 24 hours within 29 days of treatment compared with 6% of patients on placebo (30 out of 529), 2 of whom died.
December 7, 2021 - GSK and Vir Biotechnology announced an update to preclinical data demonstrating that sotrovimab retains in vitro activity against the full known Omicron (B.1.1.529) spike protein. Additionally, they announced that Management would host a conference call at 8:30 am ET, December 7, 2021, to discuss the new data.
December 2, 2021 - Xevudy (sotrovimab) was approved by the UK's Medicines and Healthcare products Regulatory Agency after it was found to be safe and effective at reducing the risk of hospitalization and death in people with mild to moderate COVID-19 infection who are at increased risk of developing severe disease.
December 2, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced an update with preclinical data demonstrating that sotrovimab retains activity against key mutations of the new Omicron SARS-CoV-2 variant (B.1.1.529), including those found in the binding site of sotrovimab. The companies are now completing in vitro pseudovirus testing to confirm the neutralizing activity of sotrovimab against the combination of all the Omicron mutations with the intent to provide an update by the end of 2021.
November 18, 2021 - The EMA confirmed it will assess the benefits and risks of Xevudy under a reduced timeline and could issue an opinion within two months, depending on whether the data submitted are sufficiently robust and whether further information is required to support the evaluation. Such a short timeframe is only possible because EMA's CHMP has already reviewed some data on the medicine during a Rolling Review.
November 17, 2021 - GSK and Vir Biotechnology announced US government contracts totaling approximately $1 billion to purchase sotrovimab. GSK would supply these doses to the US government by December 17, 2021, enabling further expanded nationwide access to sotrovimab for patients.
November 12, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced headline data from the COMET-TAIL Phase III trial was designed to evaluate the efficacy, safety, and tolerability of sotrovimab delivered via IM administration compared to IV administration in high-risk patients up to seven days after symptom onset. In the IM administration (500mg) arm of the trial, there was a 2.7% rate of progression to hospitalization for more than 24 hours or death through Day 29 of the trial, compared to 1.3% in the IV administration arm (also 500mg). The upper bound of the 95% CI is within the predetermined 3.5% non-inferiority margin set for the trial's primary endpoint in consultation with the US FDA.
October 27, 2021 - The NEJM published an ORIGINAL ARTICLE - Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab. CONCLUSIONS: Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression. No safety signals were identified in this phase 2/3 clinical trial.
October 27, 2021 - GSK announced Xevudy sales reached £114 million and received binding agreements to sell more than 420,000 doses worldwide, including a portion of those procured by the US Government. In addition, more than 220,000 doses have been reserved through other agreements.
October 4, 2021 - GSK today announced it had signed an agreement with the Government of Canada to supply 10,000 doses of Sotrovimab for injection, a COVID-19 monoclonal antibody therapy developed by GSK and Vir Biotechnology Health Canada granted authorization for Sotrovimab for injection on July 30, 2021.
October 3, 2021 - Local media reported fifteen thousand doses of sotrovimab have landed in Australia in recent days. Health Minister Greg Hunt said sotrovimab would reduce the impact of COVID-19 for many people who catch it.
September 29, 2021 - Vir Biotechnology confirmed binding agreements had been received to sell more than 420,000 doses of sotrovimab worldwide, including a portion of those procured by the US government. In addition, more than 220,000 doses have been reserved through other agreements.
September 27, 2021 - The Fred Hutch news service published: Ongoing trials test COVID-19 drugs for earlier, more accessible treatment. Injected monoclonal antibodies or oral antivirals could help more patients recover faster.
September 23, 2021 - Australia's Hon Greg Hunt MP, Minister for Health and Aged Care, announce 'that we are lifting our purchase of sotrovimab from 7,700 units to 30,000 units.'
September 14, 2021 - Local media reported UAE patients successfully treated with Sotrovimab. In addition, the Abu Dhabi Health Services Company (Seha) said its facilities have "effectively supported patients" with the treatment.
September 9, 2021 - Local media reported Brazil issued a EUA for Sotrovmab.
September 6, 2021 - GlaxoSmithKline announced that it had applied for approval to the Japanese Ministry of Health, Labour, and Welfare for sotrovimab, a single-dose, monoclonal antibody, for the treatment of COVID-19. GSK Japan seeks to obtain Special Approval for Emergency for this application.
August 27, 2021 - The Assistant Secretary for Preparedness and Response and the US Food and Drug Administration announced their commitment to ensuring timely and transparent communication regarding the COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.
August 23, 2021 - Vir Biotechnology, Inc. announced the first marketing authorization granted in Australia for sotrovimab, developed with GlaxoSmithKline Sotrovimab, the first monoclonal antibody approved in Australia. As part of its overarching effort to address COVID-19, the Australian Government also recently announced an agreement to purchase sotrovimab, the first supply of which arrived in the country last week.
August 20, 2021 - The Australian Therapeutic Goods Administration, part of the Department of Health, granted provisional approval to GlaxoSmithKline Australia Pty Ltd for its COVID-19 treatment sotrovimab (XEVUDY). Australia is the first OECD country to issue formal regulatory approval for sotrovimab (XEVUDY).
August 4, 2021 - The US NIH added sotrovimab as a recommended treatment for nonhospitalized patients with mild to moderate COVID-19 at high risk for clinical progression.
July 28, 2021 - GSK reported its financial results and disclosed Vir and GSK announced full results from the Phase III COMET-ICE trial demonstrating a 79% reduction in hospitalization for more than 24 hours or death due to any cause with early treatment with sotrovimab in adult patients with mild-to-moderate COVID-19 who are at high risk of progression to severe disease.
July 28, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they had signed a Joint Procurement Agreement with the European Commission to supply up to 220,000 doses of sotrovimab. The Joint Procurement Agreement enables participating European Union Member States to quickly purchase sotrovimab, following local emergency authorization or authorization at the EU level, to treat high-risk patients with COVID-19 who may benefit from early treatment with sotrovimab.
July 24, 2021 - Local UAE health authorities in Abu Dhabi recently announced that the medicine was 100% successful in preventing deaths and led to a recovery rate of 97% among patients. And patients at the Covid-19 Prime Assessment Center, run by Abu Dhabi Health Services Company, said they felt relieved after the treatment.
July 8, 2021 - The US National Institutes of Health updated its COVID-19 treatment guidelines to recommend sotrovimab for nonhospitalized patients with mild-to-moderate COVID-19 who are at high risk of clinical progression and noted that sotrovimab appears to retain activity against current variants of concern and interest.
June 21, 2021 - The companies issued a press statement stating: 'Analysis of final Day 29 data from COMET-ICE confirms sotrovimab significantly reduces hospitalization and risk of death in adults with mild-to-moderate COVID-19 who are at high risk of progression to severe disease. Further research was initiated to evaluate intramuscular administration of sotrovimab for the early treatment of mild-to-moderate COVID-19 in high-risk patients in a Phase 3 study.'
May 29, 2021 - The United Arab Emirates Ministry of Health and Prevention announced the emergency use Approval of the GSK, "Sotrovimab (Vir-7831)" treatment that offers the prospect of reducing hospitalization for more than 24 hours and fatalities by as much as 85% when administered to patients as an early treatment for COVID-19.
May 26, 2021 - The US FDA issued a EUA for the investigational monoclonal antibody therapy sotrovimab to treat mild-to-moderate COVID-19 in adults and pediatric patients.
May 21, 2021 - A positive scientific opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use, under Article 5(3) of Regulation 726/2004, which can be considered by the national authorities in the EU Member States when making evidence-based decisions on the early use of the medicine before marketing authorization.
May 7, 2021 - The European Medicine Agency human medicines committee confirmed it had started a 'rolling review' of data on sotrovimab (VIR-7831 and GSK4182136), a monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology, Inc. for the treatment of COVID-19.
May 7, 2021 - Vir Bio confirmed Sotrovimab, along with VIR-7832, is evaluated in Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19 VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to investigate a potential COVID-19 treatment.
April 15, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. (Nasdaq: VIR) announced that the European Medicines Agency had started a review of VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.
April 14, 2021 - Australia's Therapeutic Goods Administration (TGA) has granted a provisional determination to GlaxoSmithKline Australia Pty Ltd (GSK) concerning the monoclonal antibody treatment SOTROVIMAB (GSK4182136). The granting of an interim determination means that the TGA has decided that GSK can now apply for provisional registration for the Australian Register of Therapeutic Goods treatment.
April 8, 2021 - Vir Biotechnology, Inc. announced new preclinical research highlighting novel mechanisms by which the SARS-CoV-2 virus enters host cells and identifying how auxiliary receptors may impact the clinical efficacy of monoclonal antibodies (mAbs).
April 5, 2021 - Vir Biotechnology, Inc. announced new preclinical research demonstrating the ability of VIR-7831, the Company's investigational SARS-CoV-2 virus monoclonal antibody (mAb), to maintain its neutralizing activity against a mutation in the receptor-binding domain (RBD) of SARS-CoV-2, called L452R, which is found in the California variant (B.1.427/B.1.429). Study results also demonstrate that the L452R mutation reduced the neutralization potency of plasma from vaccinated and convalescent donors and the neutralization activity of 14 RBD-specific and 10 N-terminal domain (NTD)-specific monoclonal antibodies, including three clinical-stage mAbs.
March 29, 2021 - Vir Biotechnology, Inc., Eli Lilly and Company, and GSK plc announced topline data from the expanded Phase 2 BLAZE-4 trial studying low-risk adult patients with mild to moderate COVID-19.
March 26, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced the submission of an application to the US FDA requesting Emergency Use Authorization for VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody.
March 10, 2021 - Vir Biotechnology, Inc. and GlaxoSmithKline plc (LSE/NYSE: GSK) announced that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of profound efficacy.
March 3, 2021 - Vir Biotechnology, Inc. and GlaxoSmithKline plc announced an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial.
February 17, 2021 - GlaxoSmithKline plc and Vir Biotechnology, Inc. announced they had signed a binding agreement to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses. The expanded collaboration builds on the agreement signed in 2020 to research and develop treatments for coronaviruses.
February 1, 2021 - Vir Biotechnology, Inc. announced the publication of new research characterizing a novel site of vulnerability on the SARS-CoV-2 spike protein – specifically the N-terminal domain. Together with data on immune evasion by mutations elsewhere in the spike protein published by scientists in Cell, the study findings begin to paint a comprehensive picture of the mechanisms that SARS-CoV-2 may utilize to evade immunity Furthermore, these data collectively indicate the importance of carefully targeting conserved regions of the spike for vaccines and clinical monoclonal antibodies.
January 27, 2021 - Eli Lilly and Company, Vir Biotechnology, Inc., and GlaxoSmithKline plc announced a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19.
January 12, 2021 - Vir Biotechnology, Inc. and GlaxoSmithKline plc announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild to moderate COVID-19 in Phase 1b/2a clinical trial. VIR-7832 is a different neutralizing COVID-19 antibody that preclinical data suggests has two distinctive properties: an enhanced ability to clear infected cells and the potential to strengthen virus-specific T-cell function, which could help treat and/or prevent COVID-19 infection.
December 17, 2020 - Vir Biotechnology, Inc. and GlaxoSmithKline plc announced that the first patient had been dosed in a new sub-trial of the National Institutes of Health's Accelerating COVID-19 Therapeutic Interventions and Vaccines Program Phase 3 clinical trial.
November 6, 2020 - California based Vir Biotechnology, Inc. announced the publication of new research demonstrating that the immunodominant SARS-CoV-2 receptor binding motif (RBM) is the least conserved region in the SARS-CoV-2 spike protein, allowing for the occurrence of mutations without disrupting human ACE2 (hACE2) binding, which mediates viral entry.
October 8, 2020 - Study published by Nature: Fc-optimized antibodies elicit CD8 immunity to viral respiratory infection.
October 6, 2020 - Vir Biotechnology and GSK announce the global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 to treat COVID-19 VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs.
September 24, 2020 - RESEARCH ARTICLE: Ultrapotent human antibodies protect against the SARS-CoV-2 challenge via multiple mechanisms.
September 16, 2020 - Study published by Cell: Mapping Neutralizing and Immunodominant Sites on the SARS-CoV-2 Spike Receptor-Binding Domain by Structure-Guided High-Resolution Serology.
August 31, 2020 - Vir Biotechnology, Inc. and GlaxoSmithKline plc announced that the first patient was dosed last week in a phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization.
May 18, 2020 - Study published in Nature: Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody.
April 21, 2020 - Study: Developing therapeutic monoclonal antibodies at a pandemic pace.
Sotrovimab (Xevudy) Antibody Clinical Trials
Sotrovimab is currently conducting various clinical trials.
The results of the phase 2/3 clinical trial were published by the JAMA Network on Mar. 14, 2022: Enrollment was stopped early for efficacy at the prespecified interim analysis. Among 1057 patients randomized (median age, 53 years [IQR, 42-62], 20% were ≥65 years of age, and 65% Latinx), the median duration of follow-up was 103 days for sotrovimab and 102 days for placebo. All-cause hospitalization lasting longer than 24 hours or death was significantly reduced with sotrovimab (6/528 [1%]) vs placebo (30/529 [6%]) (adjusted relative risk [RR], 0.21 [95% CI, 0.09 to 0.50]; absolute difference, –4.53% [95% CI, –6.70% to –2.37%]; P < .001). Four of the 5 secondary outcomes were statistically significant in favor of sotrovimab, including reduced ED visit, hospitalization, or death (13/528 [2%] for sotrovimab vs 39/529 [7%] for placebo; adjusted RR, 0.34 [95% CI, 0.19 to 0.63]; absolute difference, –4.91% [95% CI, –7.50% to –2.32%]; P < .001) and progression to severe or critical respiratory COVID-19 (7/528 [1%] for sotrovimab vs 28/529 [5%] for placebo; adjusted RR, 0.26 [95% CI, 0.12 to 0.59]; absolute difference, –3.97% [95% CI, –6.11% to –1.82%]; P = .002). Adverse events were infrequent and similar between treatment groups (22% for sotrovimab vs 23% for placebo); the most common events were diarrhea with sotrovimab (n = 8; 2%) and COVID-19 pneumonia with placebo (n = 22; 4%).
The COMET-ICE: a Phase 3, multi-center, double-blind, placebo-controlled trial investigated IV infusion of sotrovimab in adults with mild-to-moderate COVID-19 at high risk of progression to severe disease, who are not hospitalized and not requiring oxygen. The final COMET-ICE trial results in the full trial population of 1,057 participants demonstrated a 79% reduction (adjusted relative risk reduction) (p<0.001) in hospitalization for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial. Interim data were published in The New England Journal of Medicine on October 27, 2021, and final data were pre-published on November 8, 2021, on medRxiv.