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Actemra / RoActemra

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July 7, 2022
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Actemra / RoActemra (tocilizumab) Description For 2022

Actemra / RoActemra (tocilizumab) is an immunomodulating medicine with an active substance, tocilizumab, a monoclonal antibody (mAbs). Actemra / RoActemra is a first-in-class anti-IL-6 receptor (aIL-6R) therapy. RoActemra attaches to the receptor for a messenger molecule or 'cytokine' called interleukin-6 (IL-6). The body's immune system produces IL-6 in response to systemic inflammation and associated respiratory failure. RoActemra prevents IL-6 from attaching to its receptors, thus blocking the pro-inflammatory effect of IL-6 cytokines.

Actemra / RoActemra is available in subcutaneous (SC) and intravenous (IV) formulations and is approved in 116 countries to treat inflammatory conditions such as rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, and cytokine release syndrome. RoActemra EMEA/H/C/000955 was initially approved in Europe in 2009. As of April 2022, about one million people hospitalized with COVID-19 have been treated with Actemra worldwide.

Actemra / RoActemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved by the U.S. FDA in 2010 to treat adult patients with moderately to severely active rheumatoid arthritis (RA) had used one or more disease-modifying antirheumatic drugs, such as methotrexate. And in May 2017, Actemra/RoActemra became the first FDA-approved treatment for adults with giant cell arteritis.

Based on the collective evidence from the Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) and Randomized Evaluation of COVID-19 Therapy (RECOVERY) trials, the COVID-19 Treatment Guidelines Panel was announced on March 5, 2021. In addition, the U.S. FDA issued an Emergency Use Authorization (EUA) on June 24, 2021, for the use of ACTEMRA to treat COVID-19 in adult and pediatric patients who are in the hospital and who are receiving corticosteroids and require supplemental oxygen or a machine that helps with their breathing (ventilator) or a device that adds oxygen to the blood outside the body. The U.S. FDA Letter of Authorisation (June 24, 2021) and Fact Sheets for patients and healthcare professionals are available for download with the latest information on this EUA.

On September 3, 2021, Genetech issued a statement: We have begun receiving scheduled replenishments of Actemra in the U.S. and anticipate additional replenishments of Actemra IV and subcutaneous (SC) formulations (ACTPen ® and prefilled syringe). Additionally, to further support COVID-19 response efforts, Genentech provided 10,000 vials of Actemra to the U.S. Strategic National Stockpile for potential future use at the direction of the U.S. Department of Health and Human Services. 

On April 3, 2022, Genentech announced that the U.S. FDA accepted a supplemental Biologics License Application and granted Priority Review for Actemra® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. A decision on U.S. FDA approval is expected in the second half of 2022. Actemra was previously granted EUA to treat COVID-19 in hospitalized adults and children in June 2021.

And on December 7, 2021, the European Commission approved its use for certain COVID-19 patients in Europe, followed by Japan on January 21, 2022. The WHO issued Precalification on February 11, 2022. The latest clinical data from the EMA was published on March 7, 2022. The EMA last updated EMEA/H/C/000955 on March 10, 2022. On June 8, 2022, the EMA published a list of critical authorized medicines for the COVID-19 public health emergency.

Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The Roche Group (SIX: RO, ROG; OTCQX: RHHBY), headquartered in Basel, Switzerland, is active in over 100 countries and 2020, employed more than 100,000 people worldwide. Genentech became a member of the Roche Group in March of 2009. For more information on how Roche is responding to the global COVID-19 pandemic, please visit Roche's COVID-19 response webpage.

Actemra / RoActemra Variants (BA.x)

Roche confirmed following the recent emergence of the new SARS-CoV-2 variant of concern, Omicron (B.1.1.529), the WHO reported in 2021 that interleukin six receptor blockers, such as Actemra/RoActemra, are expected to still be effective for managing patients with severe COVID-19. The U.S. NIH OpenData portal published updated effectiveness data on March 31, 2022.

Actemra / RoActemra Availablity

Genentech and Roche are monitoring Actemra supplies and are seeing progress toward consistent, uninterrupted patient access to Actemra IV as of April 3, 2022. However, the changing nature of the pandemic may continue to impact the availability of Actemra subcutaneous (SC) and IV formulations. The most up-to-date information about the supply of Actemra in the United States can be found on this weblink.

Actemra / RoActemra Indication

Actemra is currently approved for indications in rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. In addition, the U.S. FDA issued a EUA for the use of ACTEMRA to treat COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

In Japan, Actemra is authorized to treat Castleman's disease, rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, cytokine release syndrome induced by tumor-specific T cell infusion therapy, and adult Still's disease.

Actemra / RoActemra Dosage

Actemra® Intravenous Infusion 80 mg, 200 mg, and 400 mg are authorized in Japan for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention). 

Actemra / RoActemra Side Effects

ACTEMRA changes the way your immune system works. This can make you more likely to get infections or worsen any current infection. Some people have serious infections while taking ACTEMRA, including tuberculosis and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting and during treatment with ACTEMRA. The most common side effects (occurring in up to 1 patient in 10) with RoActemra are upper respiratory tract infections, nasopharyngitis, headache, hypertension, and abnormal liver function tests. The most serious side effects are serious infections, complications of diverticulitis, and hypersensitivity reactions. Therefore,  RoActemra must not be used in patients with an active, severe infection.

Actemra / RoActemra News for 2021 - 2022

April 3, 2022 - In a press release, Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, Roche, stated, “More than one million people with severe or critical COVID-19 have already been treated with Actemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”

March 1, 2022 - Roche stated: We continue to receive scheduled replenishments of Actemra and are closely monitoring the supply situation. At this time, the availability of Actemra SC and IV formulations continues to vary over time.

February 11, 2022 - The WHO granted prequalification status for Actemra/RoActemra for patients with severe or critical COVID-19.

January 24, 2022 - Chugai Pharmaceutical Co., Ltd. announced that it obtained regulatory approval from Japan's Ministry of Health, Labour, and Welfare for Actemra Intravenous Infusion 80 mg, 200 mg, and 400 mg for the additional indication of the treatment of SARS-CoV-2 pneumonia (limited to patients requiring oxygen intervention).

December 14, 2021 - The U.S. FDA issued interim guidance concerning certain risk evaluation and mitigation strategy requirements for chimeric antigen receptor T-cell immunotherapies due to an ongoing shortage of tocilizumab related to the COVID-19 pandemic.

December 7, 2021 - Roche announced that the European Commission had extended the marketing authorization for Actemra® / RoActemra® (tocilizumab) to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

December 6, 2021 - The EMA's human medicines committee recommended extending the indication of RoActemra (tocilizumab) to include the treatment of adults with COVID-19 who are receiving systemic therapy with corticosteroids and require supplemental oxygen or mechanical ventilation.

September 9, 2021 - The Australian Therapeutic Goods Administration issued a statement along with Roche, The Medicine Availability Working Group, and The Australian Rheumatology Association informing health providers that public hospitals will only be able to get 25% of their usual supply of intravenous Actemra, while private hospitals and community pharmacies will only receive 10%.

September 3, 2021 - Genentech provided an update on the supply of Actemra. 'Genentech and Roche are working as quickly as possible to expedite the replenishment and increase manufacturing capacity and supply, including through active collaboration with external partners. In addition, Genentech has implemented new distribution strategies for hospital and clinic customers to enable access for the greatest number of patients, as supply permits. As a result, we have begun receiving scheduled replenishments of Actemra in the U.S. and anticipate additional replenishments of all SKUs of Actemra IV and subcutaneous (SC) formulations (ACTPen ® and prefilled syringe) in the coming weeks and months. During this time, the availability of Actemra will vary. As a result, we expect additional intermittent periods of stockouts in the months ahead, especially if the pandemic continues at the current pace.'

June 25, 2021 - Roche announced the U.S. FDA had issued an Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra® (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

June 24, 2021 -  The U.S. FDA issued an emergency use authorization for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Actemra is not authorized for use in outpatients with COVID-19.

March 8, 2021 - Researchers from the University of Bristol and Medanta Institute of Education and Research in India announced a study in The Lancet Respiratory Medicine that concluded routine use of tocilizumab in patients admitted to hospital with moderate to severe COVID-19 is not supported. However, post-hoc evidence from this study suggests that tocilizumab might still be effective in patients with severe COVID-19 and should be investigated further in future studies. In addition, analysis of the data revealed a subset of patients with severe disease in whom tocilizumab might have a reduced risk for progression to death if treated with tocilizumab in addition to standard care.

March 5, 2021 - The COVID-19 Treatment Guidelines Panel issued a statement on the Use of Tocilizumab to treat COVID-19.

February 25, 2021 - The Lancet published an ORIGINAL ARTICLE: Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19. Conclusion: In critically ill patients with Covid-19 receiving organ support in ICUs, treatment with the interleukin-6 receptor antagonists tocilizumab and sarilumab improved outcomes, including survival.

February 3, 2021 - The U.S. NIH COVID-19 Treatment Guidelines Panel stated using tocilizumab that included recommendations based on a preliminary report of results from the Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia.

January 9, 2021 - U.K. found tocilizumab, developed jointly by Osaka University and Japanese firm Chugai Pharmaceutical Co., reduced the risk of death by 24% for COVID-19 patients treated with the two drugs — tocilizumab and sarilumab — within 24 hours of being taken to intensive care units.

January 7, 2021 - Research found arthritis drugs could help Covid patients. Early results from an international trial previously suggested tocilizumab might improve outcomes for those with life-threatening coronavirus infections. Both tocilizumab and sarilumab are IL-6 receptor antagonists, which dampen down the effect of proteins that can cause an overreaction of the immune system. Severe Covid has previously been linked to dangerous levels of inflammation in the body.

August 1, 2020 - A retrospective cohort study published in The Lancet examined if tocilizumab in patients with severe COVID-19 could reduce the risk of invasive mechanical ventilation and death in patients with severe COVID-19 pneumonia received standard of care treatment.

April 29, 2020 - Chinese researchers published a study in PNAS concluding from preliminary data that Actemra improved clinical outcomes immediately in 20 patients with severe or critical COVID-19, and thus "is an effective treatment to reduce mortality." Five days after treatment, 15 of the 20 patients (75%) lowered their oxygen intake, and one patient needed no oxygen therapy.

March 19, 2020 - Genentech, a Member of the Roche Group, announced it is launching a Phase III trial to assess its marketed arthritis drug Actemra® (tocilizumab) to treat adults with severe COVID-19.

May 22, 2017 - Genentech announced the U.S. FDA approved Actemra® (tocilizumab) subcutaneous injection to treat GCA, a chronic and severe autoimmune condition. This is the sixth FDA approval for Actemra since the medicine was launched in 2010.

Actemra / RoActemra COVID-19 Clinical Trials

Roche has evaluated Actemra/RoActemra in COVID-19 in three-phase III randomized studies: COVACTA, EMPACTA, and REMDACTA.

Clinical Trial NCT02735707: A Phase 4 study Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP). REMAP-CAP is a randomized, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia.

Clinical Trial NCT04372186: A Phase 3 Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia (EMPACTA)

Clinical Trial NCT04409262A Phase 3 Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Participants With Severe COVID-19 Pneumonia (REMDACTA)

Clinical Trial NCT04320615: A Phase 3 Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (COVACTA). The randomized, double-blind, placebo-controlled trial will evaluate the safety and efficacy of intravenous Actemra plus standard of care in hospitalized adults with severe COVID-19 pneumonia than placebo plus standard of care.