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EvuSheld Long-Acting Antibody

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August 14, 2022
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Evusheld (Tixagevimab plus Cilgavimab) Long-Acting Monoclonal Antibody Description

Evusheld is a Long-Acting antibody (LAAB) combination that protects against severe COVID-19. Evusheld contains infection-fighting proteins called monoclonal antibodies (mAbs). AstraZeneca's Evusheld (AZD7442) is a combination of tixagevimab (AZD8895) and cilgavimab (AZD1061), derived from B-cells donated by convalescent patients after SARS-CoV-2 beta coronavirus infections.

Antibodies are Y-shaped molecules produced naturally by the body's immune system that recognize, bind to, and neutralize specific viruses and other pathogens. Because the monoclonal antibodies bind to different parts of the protein, using them in combination has been effective. Evusheld was designed to attach to the spike protein of the SARS-CoV-2 coronavirus at two different sites and was optimized with half-life extension and reduced Fc receptor and complement C1q binding. As a result, the mAbs stop the virus from entering the body's cells and causing infection. 

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca on Jun. 9, 2020. Evusheld was engineered with AstraZeneca's proprietary half-life extension technology to increase the therapy's durability. AstraZeneca's LAABs mimic natural antibodies and have the potential to treat and prevent disease progression in patients already infected with the virus. In addition, the LAAB extension more than triples the durability of its action compared to conventional antibodies.

Evusheld was developed with support from the U.S. Government, including federal funds from the Department of Health and Human Services (HHS); Office of the Assistant Secretary for Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA) in partnership with the Department of Defense; Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, under Contract No. W911QY-21-9-0001.

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Evusheld on Dec. 8, 2021, for patients and caregivers. The EUA allows this combination to be used as pre-exposure prophylaxis (PrEP) in specific individuals who, if infected, are at high risk of progressing to severe COVID-19. And on Jun. 28, 2022, the FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of Evusheld. The U.S. CDC stated on Aug. 11, 2022, Preexposure prophylaxis with Evusheld can help protect persons with moderate to severe immunocompromise who might not mount an adequate immune response after COVID-19 vaccination, as well as persons for whom COVID-19 vaccination is not recommended because of their personal risk for severe adverse reactions. 

The U.K. issued authorization on Mar. 17, 2022, as did the European Medicines Agency (EMA) on Mar. 24, 2022, followed by the EU on Mar. 30, 2022: EMEA/H/C/005788, and Canada on Apr. 14, 2022. On June 8, 2022, the EMA published a list of critical authorized medicines (Evusheld) for the COVID-19 public health emergency. AstraZeneca AB was granted marketing authorization in the European Union.

AstraZeneca announced on June 8, 2022, that detailed results from the TACKLE Phase III outpatient treatment study showed Evusheld provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo, with treatment with Evusheld earlier in the disease course leading to more favorable outcomes.

On Jun. 29, 2022, the FDA revised its recommendation stating: Nonclinical data and pharmacokinetic modeling suggest that activity against the currently circulating SARS-CoV-2 variants and subvariants may be retained for six months at drug concentrations achieved following an Evusheld dose of 300 mg of tixagevimab and 300 mg cilgavimab. And the U.S. CDC published an updated guide for 'People Who Are Immunocompromised.' 

On Jul. 7, 2022, The Lancet Respiratory Medicine published detailed results from the TACKLE Phase III outpatient treatment trial that showed Evusheld provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo, with treatment with Evusheld earlier in the disease course leading to more favorable outcomes. Then on Jul. 8, 2022, The Lancet published: Tixagevimab–cilgavimab for treatment of patients hospitalized with COVID-19: a randomized, double-blind, phase 3 trial - Interpretation: Among patients hospitalized with COVID-19 receiving remdesivir and other standard care, tixagevimab–cilgavimab was safe and led to a 30% relative risk reduction for mortality up to day 90. The absolute risk reduction was 3.6%. 

AstraZeneca (LSE/STO / Nasdaq: AZN), located in Cambridge, UK, and Delaware, operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. Visit astrazeneca.com for additional information. The Brand Institute partnered with AstraZeneca in developing the brand name EVUSHELD™.

Evusheld BA.x Subvariants

As of Aug. 4, 2022, the U.S. NIH OpenData Portal reported Evusheld in vitro Therapeutic Activity against SARS-CoV-2 virus variants. On Jul. 21, 2022, neutralization data in line with previous data against Omicron BA.5 is now included in the revised Evusheld US Fact Sheet. And AstraZeneca announced on May 25, 2022, that Evusheld retains neutralization activity against the emerging Omicron BA.4 and BA.5 (BA.4/5) variants, according to preclinical pseudovirus assay data (May 23, 2022) from the University of Oxford. On Mar. 28, 2022, AstraZeneca confirmed a growing body of evidence supporting the potential of Evusheld to protect against the BA.1, BA.1.1, and BA.2 Omicron SARS-CoV-2 subvariants.

Evusheld Availability

AstraZeneca received Emergency Use Authorization for EVUSHELD from the U.S. FDA on Dec. 8, 2021. Since then, about 808,008 Evusheld doses have been distributed in the U.S. On Aug. 1, 2022, the U.S. HHS's Assistant Secretary for Preparedness and Response (ASPR) confirmed (203,760) that additional doses of Evusheld would be distributed. The HHS oversees the allocation and distribution of Evusheld in the USA. On July 27, 2022, HHS/ASPR partnered with AstraZeneca to establish an additional pathway for providers to access Evusheld for use with eligible patients.

On Feb. 11, 2022, the U.S. Defense Department awarded AstraZeneca an $855 million contract to manufacture, distribute, and store Evusheld for the general population. Previously AstraZeneca agreed to supply the US government with 700,000 additional doses of Evusheld.

On Nov. 14, 2021, Bahrain became the first country of (32) to Approve Evusheld, followed by Abu DhabiAustralia, BelgiumCanadaEgypt, France, IsraelSpainSouth Korea, MalaysiaSouth Korea, Thailand, and Switzerland. On Mar. 17, 2022, the UK approved Evushild.

Evusheld At Pharmacy

On July 29, 2022, NPR reported Evusheld would become available in the USA through a subset of federal pharmacy partners, including Albertsons, Acme, Jewel-Osco, Pavilions, Randalls, Safeway, Star Market, Vons, CPESN, Amber Specialty Pharmacy, Managed Healthcare Associates and Thrifty White. AstraZeneca offered a toll-free number (1-833-EVUSHLD — 1-833-388-7453) for health care providers to access ordering information.

On July 12, 2022, the U.S. Administration announced it would make effective pre-exposure prophylactics such as Evusheld more widely available through enhanced distribution to clinicians’ offices and clinics. Previously, Amber Specialty Pharmacy (Hy-Vee) announced on June 23, 2022, the launch of expanded EVUSHELD services at 19 locations.

Evusheld Dosage

Patients receive one dose of EVUSHELD, composed of two separate injections, given by a healthcare provider as two intramuscular injections. On Jun. 29, 2022, the FDA revised the Evusheld Fact Sheet for Healthcare Providers to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection.

And in Europe, the recommended dosage of Evusheld is 150mg of tixagevimab and 150mg of cilgavimab, administered as two separate sequential intramuscular injections. However, laboratory studies show that the Omicron BA.1 variant may be less sensitive to tixagevimab and cilgavimab at 150 mg doses than the Omicron BA.2 variant.

Evusheld History

In a Nature publication in Jul. 2020, the LAAB was shown in preclinical experiments to block the binding of the SARS-CoV-2 virus to host cells and protect against infection in cell and animal models of disease. On Dec. 25, 2020, Dr. Houlihan of UCL Infection & Immunity said: "We know that this antibody combination (tixagevimab and cilgavimab) can neutralize the virus, so we hope to find that giving this treatment via injection can lead to immediate protection against the development of Covid-19 in people who have been exposed – when it would be too late to offer a vaccine."

On Feb. 3, 2021, AstraZeneca stated, 'While vaccines train the immune system to fight a future infection, monoclonal antibodies mimic naturally developed antibodies to neutralize SARS-CoV-2 infection immediately.' On Aug. 20, 2021, the Company announced AZD7442 PROVENT Phase III prophylaxis trial met the primary endpoint in preventing COVID-19: 77% reduced risk of developing symptomatic COVID-19. Dr. Myron J. Levin, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, U.S., and principal investigator of the trial, said in a press release issued on Aug. 20, 2021, "The PROVENT data show that one dose of AZD7442, delivered in a convenient intramuscular form, can quickly and effectively prevent symptomatic COVID-19. With these exciting results, AZD7442 could be an important tool in our arsenal to help people who may need more than a vaccine to return to their normal lives."

On Apr. 20, 2022, the NEJM published a peer-reviewed Original Article that reviewed a phase 3 study concluding, 'A single dose of AZD7442 had efficacy for preventing Covid-19, without evident safety concerns.' Symptomatic Covid-19 occurred in 8 of 3441 participants (0.2%) in the AZD7442 group; extended follow-up at a median of six months showed a relative risk reduction of 82.8% (95% CI, 65.8 to 91.4). The peer-review journal The Lancet published the findings from an AstraZeneca phase 3 study that concluded 'a single intramuscular tixagevimab–cilgavimab (Evusheld) dose provided statistically and clinically significant protection against progression to severe COVID-19 or death versus placebo in unvaccinated individuals and safety was favorable.

Evusheld Indication

The Evusheld product is authorized for those individuals who are not currently infected with the SARS-CoV-2 coronavirus and who have not recently been exposed to an individual infected with SARS-CoV-2. The authorization also requires that individuals either have moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines. In addition, individuals who have received a COVID-19 vaccine, EVUSHELD, should be administered at least two weeks after vaccination.

The U.S. CDC published 'People Who Are Immunocompromised' on June 29, 2022: Evusheld is authorized as pre-exposure prophylaxis (PrEP) for the prevention of COVID-19. It is given before you get exposed or test positive to help prevent COVID-19 infection. Evusheld is not used to treat COVID-19 symptoms. It is also not a substitute for COVID-19 vaccination. Do not take EVUSHELD if you have had a severe allergic reaction to EVUSHELD.

The JAMA Network published a Medical Lette on Jan. 25, 2022, in a double-blind trial, one-time IM administration of the antibodies decreased the incidence of symptomatic COVID-19 compared to placebo in at-risk adults for 6 months. And Evusheld (tixagevimab and cilgavimab) can be administered to eligible patients every six months while SARS-CoV-2 is in circulation.

Evusheld Adolescents 

Australia granted Provisional Determination to Astrazenecas's Evusheld for adolescents (12+) on Jan. 4, 2022. As did Europe on Mar. 28, 2022.

Evusheld and Multiple Sclerosis

In a study published on May 21, 2022 - Tixagevimab and Cilgavimab (Evusheld) boost antibody levels to SARS-CoV-2 in patients with multiple sclerosis on b-cell depleters - In this study, patients with MS who had an attenuated antibody response to COVID-19 vaccines due to exposure to b-cell depleters now had the highest antibody response possible after receiving Evusheld.

Evusheld and Cancer

On July 19, 2022, MD Anderson, based in Texas, wrote: Cancer and COVID-19: What protection do PAXLOVID, EVUSHELD therapies provide?

A recent study retrospectively analyzed serologic responses to initial and booster COVID-19 vaccination and mAbs treatment in 378 patients with hematologic (blood cancer) malignancy. None of the twenty-five cancer patients given tixagevimab-cilgavimab tested positive for the coronavirus. Dr. Ollila stated in a press release issued on Jul. 11, 2022, “Moreover, when we looked at outcomes, we found that deaths from COVID-19 in the patient population we reviewed only occurred in those with undetectable antibodies, and nobody who received prophylactic antibody therapy was diagnosed with COVID-19. This suggests to us the importance of checking antibody levels in these patients and arranging prophylactic antibody therapy.”

Evusheld Side Effects

The most common adverse effects of tixagevimab plus cilgavimab in the PROVENT study were headache (6%) and fatigue (4%). Rates of overall and serious adverse events in the antibody and placebo groups were similar. In the post-hoc analysis of PROVENT, the incidence of serious cardiac adverse events (myocardial infarction, cardiac failure, arrhythmia) was higher in the antibody group than in the placebo group (0.6% vs 0.2%). One person who received the antibodies died of myocardial infarction. There was no clear temporal relationship between antibody administration and cardiac adverse events.

Evusheld Payments

During the COVID-19 Public Health Emergency, the U.S. CMS pays for mAbs infusions (consistent with 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 specific administration codes (M0220, M0221) for Medicare payment.

Evusheld Sales

AstraZeneca reported on July 29, 2022, that second-quarter sales of Evusheld were $445 million. On April 29, 2022, AstraZeneca reported first-quarter 2022 results for Evusheld of $469 million.

On February 10, 2022, AstraZeneca reported its financial disclosures, which announced minimal revenues from Evusheld sales in 2021. Under the terms of the licensing agreement with Vanderbilt University, AstraZeneca will pay single-digit royalties on future net sales.

Evusheld News

August 12, 2022 - The BBC reported the UK Department of Health confirmed it would not be buying Evusheld.

August 11, 2022 - The U.S. CDC announced that Evusheld could help protect persons who are moderate to severe immunocompromised.

July 30, 2022 - The dailyMail reported more than 100 doctors and 19 charities in the U.K had requested the NHS fund access to Evusheld.

July 29, 2022 - NPR reported a Health and Human Services Department spokesperson commented: "This new (ASPR pharmacy) pathway will be particularly beneficial for health care providers in rural areas and others (up to three patient courses at a time) that do not have a large pool of patients requiring the therapy."

July 21, 2022 - StatNews reported an analysis of ten states found that immunocompromised people accounted for 12.2% of all Covid-related hospitalizations, despite being only 3% of the U.S. population. Health and Human Services therapeutics director Meghan Pennini acknowledged that only around 165,000 people had received the drug, according to a transcript obtained by STAT. 

July 20, 2022 - Data published in the NEJM show that Evusheld (tixagevimab and cilgavimab) retains neutralizing activity against Omicron subvariants, including Omicron BA.5, BA.4, and BA.21.

July 20, 2022 - Reuters reported Switzerland intends to acquire about over 1.2K doses of Evusheld.

July 8, 2022 - Mene Pangalos, EVP, BioPharmaceuticals R&D, AstraZeneca, said in a press release: "We are discussing the TACKLE phase 3 data with regulatory authorities and continue to progress submissions in both treatment and prophylaxis indications to help combat COVID-19 on all fronts."

July 6, 2022 - China's regulatory agency issued authorization for Evusheld's use to AstraZeneca Plc.

July 1, 2022 - The U.S. FDA stated, 'Nonclinical data and pharmacokinetic modeling suggest that activity against the currently circulating SARS-CoV-2 variants and subvariants may be retained for six months at drug concentrations achieved following an Evusheld dose of 300 mg of tixagevimab and 300 mg cilgavimab.'

June 29, 2022 - Thailand's Food and Drug Administration director Paisal Dankhum approved the use of Evusheld for the prevention of Covid-19.

June 28, 2022 - The U.S. FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated Evusheld.

June 8, 2022 - Mene Pangalos, EVP, BioPharmaceuticals R&D, AstraZeneca, said in a press release: "These results published in The Lancet Respiratory Medicine add to the growing evidence supporting the use of Evusheld to help patients who most need additional protection against COVID-19. We are discussing the TACKLE data with regulatory authorities and continue to progress submissions in both treatment and prophylaxis indications to help combat COVID-19 on all fronts."

May 23, 2022 - A non-peer-reviewed study published by the University of Oxford confirmed AZD7442 retains neutralization activity against the emerging Omicron BA.4 and BA.5 (BA.4/5) variants.

May 17, 2022 - RQ Bio announced a successful licensing deal with AstraZeneca for RQ Bio's existing mAbs against SARS-CoV-2. Under the terms of the agreement, RQ Bio has granted AstraZeneca an exclusive worldwide license to develop, manufacture, and commercialize RQ Bio's existing early-stage mAbs against SARS-CoV-2 and a right of first refusal to take an exclusive license in respect of any additional mAbs against SARS-CoV-2.

May 13, 2022 - The Malaysian Ministry of Health announced the Drug Control Authority's conditional approval of the Evusheld mAbs.

May 5, 2022 - Chief Public Health Officer Dr. Heather Morrison said told CBC News that Canada's PEI province will get 100 doses of the antibody therapy Evusheld.

May 5, 2022 - "The key to ending the COVID-19 pandemic (in New Brunswick) is protecting as many people as possible against infection, including those who may need an additional layer of protection to prevent COVID-19 than vaccines alone can provide," said Kiersten Combs. The approval of Evusheld, she said, is "an important step along this journey."

May 5, 2022 - Taylor Francis Online published: COVID-19 vaccine-associated transverse myelitis-Evusheld as an option when vaccination is not recommended due to severe adverse events. 'We report the safe administration of Evusheld to a patient who experienced transverse myelitis 11 months previously as a result of receiving the Moderna mRNA vaccine. This patient has experienced no adverse events to Evusheld.'

April 21, 2022 - AstraZeneca US announced pre-exposure prophylaxis phase 3 clinical trial found up to 83% reduction of symptomatic COVID-19 risk, with no severe disease or COVID-19-related deaths in the EVUSHELD group.

April 20, 2022 - The New England Journal of Medicine published the findings from a phase 3 randomized clinical trial focused on the monoclonal antibody combination tixagevimab-cilgavimab (Evusheld) - which reduced the risk of symptomatic COVID-19 infection by 83% over placebo at a median follow-up of 6 months.

April 14, 2022 - Canada confirmed Evusheld was authorized, as did the U.K. in March 2022.

April 14, 2022 - The AMA published an article: 3 tips for doctors on using Evusheld for COVID-19 protection.

April 13, 2022 - CNN published an Opinion: There's a drug to protect the most vulnerable from Covid-19. Why is it so hard to get?

March 28, 2022 - AstraZeneca plc announced Evusheld, a long-acting antibody combination, was approved in the EU for pre-exposure prophylaxis of COVID-19 in a broad population.

March 19, 2022 - A non-peer-reviewed study: Breakthrough Covid-19 cases despite Evusheld prophylaxis in kidney transplant recipients - Pre-exposure prophylaxis with a 'lower dose' of Evusheld provided 90% protection KTRs against Omicron. Of the 416 KTRs who received intramuscular prophylactic injections of Evusheld (150 mg tixagevimab and 150 mg cilgavimab), 39 (9.4%) developed COVID-19.

March 18, 2022 - A non-peer-reviewed study - Resilience of S309 and AZD7442 monoclonal antibody treatments against infection by SARS-CoV-2 Omicron lineage strains - demonstrates the resilience of S309 and AZD7442 mAbs against emerging SARS-CoV-2 variant strains in mice and provide insight into the relationship between loss of antibody neutralization potency and retained protection in vivo.

March 17, 2022 - The U.K.'s decision to grant approval for Evusheld was endorsed by the government's independent expert scientific advisory body, the Commission on Human Medicines, after carefully reviewing the evidence.

March 15, 2022 - Reuters reported the EMA had begun reviewing Evusheld for use in Europe.

March 14, 2022 - HealthDay reported according to NEJM findings on March 9, 2022, the most effective antibody treatment against the BA.2 variant was Evusheld.

March 6, 2022 - The New York Times reported the U.S. administration has purchased 1.7 million doses and had nearly 650,000 doses ready for distribution as of this past week. However, the government's distribution disclosure indicates 49,992 doses were sent to states, territories, or agencies.

March 3, 2022 - The EMA Tweeted: The rolling review of the monoclonal antibodies Evusheld has progressed. In the next few weeks, we could move towards the submission of a marketing authorization application.

February 24, 2022 - The U.S. FDA announced changes to Evusheld's dosing schedule - the initial authorized dose is 300 mg of tixagevimab and 300 mg of cilgavimab.

February 11, 2022 - The U.S. government (DoD) awarded AstraZeneca an $855,000,000 modification (P00005) to contract W911QY-20-C-0119 for the manufacture, distribution, and storage of AZD7442 to treat COVID-19 in the general population. Work will be performed in various locations, with an estimated completion date of March 31, 2023.

February 4, 2022 - ABC27 reported: "If you get a call about Evusheld, say yes," said Tami Minnier, Chief Quality & Operational Excellence Office at UPMC. Evushled is offered at UPMC locations in the Midstate.

January 26, 2022 - Local media reported Egypt's Ministry of Health and Population will soon receive its first shipment of Evusheld. The shipment includes enough doses of Evusheld to treat 50,000 people and will be distributed amongst hospitals.

January 25, 2022 - NPR wrote an article: Hospitals use a lottery to allocate scarce COVID drugs for the immunocompromised.

January 12, 2022 - CNN reported the U.S. government is "in the process of ordering another half-million course of AstraZeneca's Evusheld, Covid-19 response coordinator Jeff Zients said at Wednesday's Covid-19 briefing.

January 4, 2022 - In Pennsylvania, UPMC, Penn State, Penn Medicine Lancaster, and WellSpan Health have all received doses of the drug. UPMC said it has received 456 doses for at least 800,000 patients that qualify. "So we can treat the sickest of the sick."

December 23, 2021 - AstraZeneca announced EVUSHELD retained neutralization activity against the Omicron SARS-CoV-2 variant, according to new authentic 'live' virus neutralization data from the University College Oxford, UK, and Washington University School of Medicine, St. Louis, US.

December 17, 2021 - Florida's governor stated during an interview in Ocala Evusheld would soon become available. There is currently a standing order in Florida signed by the State Surgeon General that allows patients to receive this treatment without a prescription or referral if administered by an eligible health care provider.

December 16, 2021 - AstraZeneca today announced EVUSHELD retained neutralizing activity against the Omicron SARS-CoV-2 variant (B.1.1.529), according to new preclinical data.

December 14, 2021 - Samsung Biologics will begin manufacturing AstraZeneca's COVID-19 antibody combination Evusheld.

December 8, 2021 - AstraZeneca confirmed today Evusheld, a long-acting antibody combination, has received emergency use authorization in the U.S. for the pre-exposure prophylaxis of COVID-19, with first doses expected to become available very soon.

December 8, 2021 - The U.S. FDA issued a EUA for Evusheld (tixagevimab co-packaged with cilgavimab).

November 19, 2021 - The BMJ reported AstraZeneca's AZD7442 long-lasting experimental treatment effectively prevents and reduces severe COVID-19 illness.

November 18, 2021 - AstraZeneca reported new data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time intramuscular (I.M.) dose of the long-acting antibody (LAAB) combination. In addition, an analysis of the ongoing PROVENT trial evaluating a median of six months of participant follow-up, one 300mg I.M. dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%.

November 9, 2021 - BioSpace reported AstraZeneca plans to create a separate division for vaccines and antibody therapies. The focus will be on its COVID-19 vaccine developed with the University of Oxford and other COVID-19 antibody treatments.

October 14, 2021 - The EMA's human medicines committee started a rolling review of Evusheld (AZD7442) being developed by AstraZeneca AB to prevent COVID-19 in adults.

October 11, 2021 - AstraZeneca announced positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AstraZeneca's AZD7442 LAAB combination achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild-to-moderate symptomatic COVID-19. A total of 90% of participants enrolled were from populations at high risk of progression to severe COVID-19, including those with co-morbidities.

October 5, 2021 - AstraZeneca announced it had submitted a request to the U.S. FDA for an Emergency Use Authorization for AZD7442, its long-acting antibody combination, to prevent symptomatic COVID-19. If granted, AZD7442 would be the first LAAB to receive a EUA for COVID-19 prevention. The EUA request filing includes safety and efficacy data from the PROVENT and STORM CHASER Phase III trials and the Phase I trial.

September 27, 2021 - AstraZeneca announced today it will present data across its COVID-19 and respiratory syncytial virus pipeline at the 10th Annual IDWeek Virtual Conference. In addition, data featuring AstraZeneca's investigational long-acting antibody programs – AZD7442 for COVID-19 and nirsevimab for RSV – as well as AZD1222, will be presented as three late-breaking oral presentations.

August 20, 2021 - AstraZeneca announced the AZD7442 PROVENT Phase III prophylaxis trial met the primary endpoint in preventing COVID-19. AZD7442 achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial's primary endpoint.

August 20, 2021 - A monoclonal antibody cocktail against the COVID-19 virus discovered at Vanderbilt University Medical Center and developed by AstraZeneca reduced the risk of symptoms in a study of immunocompromised and chronically ill adults later exposed to the virus by 77%.

June 15, 2021 - AstraZeneca announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442. Compared to placebo, the trial did not meet the primary endpoint of post-exposure prevention of symptomatic COVID-19 with AZD7442.

February 8, 2021 - The U.S. NIH published: Clinical trial in hospitalized COVID-19 patients evaluates long-acting antibody therapy.

October 9, 2020 - Two trials of AZD7442 will enroll over 6,000 adults to prevent COVID-19, with additional trials enrolling ~4,000 adults for the treatment of SARS-CoV-2 infections.

July 15, 2020 - Study published by Nature: Potently neutralize and protect human antibodies against SARS-CoV-2. In two mouse models of SARS-CoV-2 infection, passive transfer of COV2-2196, COV2-2130, or a combination of both of these antibodies protected mice from weight loss. Furthermore, it reduced the viral burden and levels of inflammation in the lungs.

June 9, 2020 - Vanderbilt University Medical Center discovered the human monoclonal antibodies and licensed them to AstraZeneca. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales.

April 8, 2020 - The Chinese Academy of Sciences and Vanderbilt University Medical Center provides AstraZeneca with genetic sequences for antibodies discovered against SARS-CoV-2 for further in silico and in vitro assessment.

Evusheld Clinical Trials

Visit AstraZeneca for more sponsored trial information. 

ClinicalTrials.gov Identifier: NCT04723394 - Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults (TACKLE) - Findings: Between Jan 28, 2021, and July 22, 2021, 1014 participants were enrolled, of whom 910 were randomly assigned to a treatment group (456 to receive tixagevimab–cilgavimab and 454 to receive placebo). The mean age of participants was 46·1 years (SD 15·2). Severe COVID-19 or death occurred in 18 (4%) of 407 participants in the tixagevimab–cilgavimab group versus 37 (9%) of 415 participants in the placebo group (relative risk reduction 50·5% [95% CI 14·6–71·3]; p=0·0096). The absolute risk reduction was 4·5% (95% CI 1·1–8·0; p<0·0001). Adverse events occurred in 132 (29%) of 452 participants in the tixagevimab–cilgavimab group and 163 (36%) of 451 participants in the placebo group and were mostly of mild or moderate severity. There were three COVID-19-reported deaths in the tixagevimab–cilgavimab group and six in the placebo group.

Based on the results of PROVENT (Clinical Trial NCT04625725) - the U.S. FDA issued an Emergency Use Authorization on December 8, 2021, for the anti-SARS-CoV-2 monoclonal antibodies tixagevimab plus cilgavimab (Evusheld). Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adults. (PROVENT). The PROVENT study will assess the safety and efficacy of a single dose of AZD7442(× 2 I.M. injections) compared to a placebo to prevent COVID-19. AstraZeneca presented an abstract at IDWeek that this study hit the primary endpoint in preventing COVID-19.

Clinical Trial NCT04507256:  AZD7442 is a Potential Combination Therapy for the Prevention and Treatment of COVID-19. In this first-in-human dose-escalation study, AZD7442 (AZD8895 + AZD1061) will be evaluated for safety, tolerability, and pharmacokinetics generation of anti-drug antibodies (ADAs). In addition, the study is intended to enable future studies of AZD7442's efficacy in preventing and treating COVID-19. The study will comprise of: A Screening Period of up to 27 days (Day -28 through Day -2); A Treatment Period during which participants will be resident at the Clinical Unit from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day 1) until at least 24 hours after IMP administration, will be discharged on Day 2 after all safety evaluations have been completed, and a Follow-up Period lasting 360 days (through to Day 361) after the IMP dose.

Ongoing trials include TACKLE COVID-19, a Phase III mild-to-moderate COVID-19 outpatient treatment trial, and collaborator treatment trials in outpatient and hospitalized settings. TACKLE is a Phase III, randomized, double-blind, placebo-controlled, multi-center trial assessing the safety and efficacy of a single 600mg I.M. dose of AZD7442 compared to a placebo for the outpatient treatment COVID-19. The trial was conducted in 96 sites in Brazil, Czech Republic, Germany, Hungary, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Ukraine, U.K., and U.S. 903 participants were randomized (1:1) to receive either AZD7442 (n = 452) or saline placebo (n = 451), administered in two separate, sequential IM injections. Participants were adults 18 years old and over who were non-hospitalized with mild-to-moderate COVID-19 and symptomatic for seven days or less. Participants had a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (e.g., oropharyngeal, nasopharyngeal, or nasal swab or saliva) collected no more than three days before day one. The primary efficacy endpoint was the composite of severe COVID-19 or death from any cause until day 29. Subjects will continue to be followed for 15 months. Approximately 13% of participants were 65 years and over. In addition, 90% had baseline co-morbidities and other characteristics that put them at high risk of progression to severe COVID-19, including cancer, diabetes, obesity, chronic lung disease or asthma, cardiovascular disease, or immunosuppression. Approximately 62% were White/Caucasian, 4% Black/African-American, 6% Asian, and 24% American Indian or Alaskan Native. About 52% of participants were Hispanic/Latino.

Clinical Trials

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