Actemra / RoActemra (Tocilizumab) Description
Actemra (RoActemra) was the first humanized interleukin-6 (IL-6) receptor antagonist approved by the U.S. FDA for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX). The FDA approved Actemra in 2010. Actemra/RoActemra is approved in 116 countries.
The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. Actemra / RoActemra is approved in 116 countries for the treatment of RA. In addition, RoActemra EMEA/H/C/000955 was approved in Europe in 2009.
The US Food and Drug Administration has issued an Emergency Use Authorization 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 machine that adds oxygen to the blood outside the body.
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.
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 were announced on March 5, 2021. 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 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. We expect additional intermittent periods of stockouts in the months ahead, especially if the pandemic continues at the current pace.
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, 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.
Actemra / RoActemra (Tocilizumab) 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. Actemra® (tocilizumab) 400 mg/20 mL vial for intravenous use.
Actemra is also in clinical studies to assess if Actemra is an effective treatment for adults with severe COVID-19. However, in some patients with COVID-19, the immune response runs amok, overexpressing IL-6 and generating a “cytokine storm,” leading to potentially life-threatening damage to lungs and other organs.
ACTEMRA® (TOCILIZUMAB) is not Approved by the U.S. FDA. However, the US Food and Drug Administration has issued an Emergency Use Authorization (EUA) for 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.
You should also refer to the CDC website and information from state and local health authorities regarding reports of SARS-CoV-2 viral variants of importance in their region to guide treatment decisions. Or, call medical information about Genentech medicines at (800) 821-8590.
Actemra / RoActemra (Tocilizumab) Side Effects
ACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. 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.
Actemra / RoActemra (Tocilizumab) News
September 9, 2021 - The 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, a member of the Roche Group, 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. 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. Food and Drug Administration 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. The EUA is based on results from four randomized, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. The results of these studies suggest that Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
June 24, 2021 - The U.S. Food and Drug Administration 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 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. finds Japanese arthritis drug is effective for COVID-19 treatment. Tocilizumab was developed jointly by Osaka University and Japanese firm Chugai Pharmaceutical Co. In clinical trials funded by the government, the risk of death dropped by 24% for COVID-19 patients treated with the two drugs — tocilizumab and sarilumab — within 24 hours of being taken to intensive care units, it said, adding that the drugs can also shorten the period of hospitalization of patients by seven to 10 days.
January 7, 2021 - Arthritis drugs could help save the lives of Covid patients, research finds. 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. This retrospective, observational cohort study included adults (≥18 years) with severe COVID-19 pneumonia who were admitted to tertiary care centers in Bologna and Reggio Emilia, Italy, between Feb 21 and March 24, 2020, and a tertiary care center in Modena, Italy, between Feb 21 and April 30, 2020. The study interpretation was that the treatment with tocilizumab, whether administered intravenously or subcutaneously, might reduce the risk of invasive mechanical ventilation or death in patients with severe COVID-19 pneumonia.
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 1 patient needed no oxygen therapy.
April 29, 2020 - UC San Diego Health has launched a Phase III clinical trial, part of a global effort, to assess whether a medication used to treat rheumatoid arthritis and other inflammatory disorders might also have therapeutic value for COVID-19 patients who have developed or at high risk of developing serious lung damage from SARS-CoV-2 infections.
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. Food and Drug Administration (FDA) had approved Actemra® (tocilizumab) subcutaneous injection to treat GCA, a chronic and severe autoimmune condition. Actemra is the first therapy approved by the FDA for the treatment of adult patients with GCA. This is the sixth FDA approval for Actemra since the medicine was launched in 2010.
Actemra COVID-19 Clinical Trials
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 NCT04409262: A 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.