The FDA has granted an Emergency Use Authorization (EUA) which enables the treatment of COVID-19 in hospitalized adult and pediatric patients, 2 years of age and older, with Genentech’s Actemra.
Genentech, a Roche Group company announced the EUA of Actemra® (tocilizumab) granted by the FDA for intravenous administration and treatment of COVID-19 in hospitalized adults and pediatric patients, 2 years of age and older, who are receiving systemic corticosteroids and need supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Actemra is now an option for hospitalized adults and children with COVID-19 in the U.S.
The EUA is based on data from four randomized, controlled trials that studied Actemra’s safety and efficiency in over 5,500 hospitalized patients for COVID-19 therapy.
Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development stated:
“Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalizations from severe forms of the disease. We are pleased that Actemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19 in the United States.”
Alexander Hardy, Chief Executive Officer said:
“Industries, governments and academic institutions have come together to develop solutions to address the enormous challenges of the pandemic. We are proud of the partnerships that we’ve created and the progress we’ve made in conducting scientifically rigorous trials of Actemra in COVID-19. We are committed to collaborating closely with our distribution partners to enable access to Actemra in hospitals across the country to help adults and children with COVID-19, as well as people who depend on the medicine for its FDA-approved indications.”
Furthermore, over 4,000 COVID-19 patients have participated in the RECOVERY Actemra study l, which was led by scientists in the United Kingdom. The placebo-controlled EMPACTA, COVACTA, and REMDACTA studies were among the Genentech-sponsored global trials. In all of these investigations, no new safety signals for Actemra were identified. Constipation, diarrhea, and anemia are the most prevalent side effects (incidence 3%).
About the Emergency Use Authorization (EUA) for Actemra
Actemra has not been approved by the U.S. FDA in this setting, but the FDA has made Actemra available under an emergency access mechanism called an EUA as a treatment for certain patients with COVID-19. There is limited information known about the safety or effectiveness of using Actemra to treat people in hospitals with COVID-19. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. The authorization is temporary and does not replace the formal review and approval process. Actemra is authorized under the EUA only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Actemra under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Genentech has existing distribution channels established to ship Actemra to hospitals across the United States.
About the Actemra COVID-19 Clinical Trial Program
Genentech’s clinical trial program evaluated the safety and efficacy of Actemra in hospitalized patients with COVID-19. Actemra is not FDA-approved for this use and there is limited information known about the safety or effectiveness of using Actemra to treat people in the hospital with COVID-19. COVACTA and EMPACTA were the first two global Phase III, multicenter, randomized, placebo-controlled studies of Actemra in patients hospitalized with COVID-19 associated pneumonia. COVACTA was conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services (HHS). EMPACTA aimed to address research questions about the safety and efficacy of Actemra in underserved populations by emphasizing enrollment from minority patients often underrepresented in clinical trials. Both studies were published in the New England Journal of Medicine.
Genentech also partnered with Gilead Sciences, Inc., on REMDACTA, a Phase III, randomized, double-blind, multicenter study to evaluate the safety and efficacy of Actemra plus Veklury® (remdesivir), versus placebo plus Veklury, in hospitalised patients with severe COVID-19 associated pneumonia.
Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved 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), that did not provide enough relief. 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. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra subcutaneous injection is also approved for the treatment of adult patients with giant cell arteritis (GCA), for the treatment of patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), and for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
In addition, Actemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA or CAR T cell-induced cytokine release syndrome (CRS). Actemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra is safe and effective in children with PJIA, SJIA or CRS under two years of age or in children with conditions other than PJIA, SJIA or CRS.
Actemra is intended for use under the guidance of a healthcare practitioner.
Founded more than four decades years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.