Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults

  • If approved, Actemra/RoActemra would be the first U.S. FDA-approved immunomodulator for the treatment of COVID-19 in hospitalised patients
  • Since the beginning of the pandemic, more than one million people hospitalised with COVID-19 have been treated with Actemra/RoActemra worldwide1
  • Actemra/RoActemra is approved for the treatment of COVID-19 in many territories including the European Union
  • Roche has established a comprehensive access approach to improve availability of Actemra/RoActemra around the world

 today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra®/RoActemra® (tocilizumab) intravenous for the treatment of COVID-19 in hospitalised 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 this year.

“The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development, Roche. “More than one million people with severe or critical COVID-19 have already been treated with Actemra/RoActemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”

The sBLA submission is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients. Altogether, the results of these four studies (EMPACTA, COVACTA, REMDACTA, and RECOVERY) suggest that Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.

Providing Actemra/RoActemra at cost to WHO and partners of the Access to COVID-19 Tools Accelerator (ACT-A) Initiative, building on the significant portion of Actemra/RoActemra supply that Roche has provided to upper-middle- and lower-middle-income countries since the beginning of the pandemic.7
Implementing an international differentiated pricing strategy specifically designed to address needs during this pandemic and improve affordability.7
Following the emergence of the SARS-CoV-2 variant of concern, Omicron (B.1.1.529), in December 2021 WHO reported that interleukin-6 receptor blockers, such as Actemra/RoActemra, are expected to still be effective for managing patients with severe COVID-19.9

Roche stands together with society, governments, healthcare providers and all those working towards the common goal of overcoming the COVID-19 pandemic.

About the Actemra®/RoActemra® (tocilizumab) COVID-19 Clinical Trial Programme
Roche’s clinical trial programme evaluated the safety and efficacy of Actemra/RoActemra in hospitalised patients with COVID-19. Actemra/RoActemra is not U.S. Food and Drug Administration (FDA)-approved for this use and there is limited information known about the safety or effectiveness of using Actemra/RoActemra to treat people in the hospital with COVID-19. COVACTA and EMPACTA were the first two global phase III, multicentre, randomised, placebo-controlled studies of Actemra/RoActemra in patients hospitalised 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/RoActemra in underserved populations by emphasising enrollment from minority patients often underrepresented in clinical trials. Both studies were published in the New England Journal of Medicine. Roche also partnered with Gilead Sciences, Inc., on REMDACTA, a phase III, randomised, double-blind, multicentre study to evaluate the safety and efficacy of Actemra/RoActemra plus Veklury® (remdesivir), versus placebo plus Veklury, in hospitalised patients with severe COVID-19 associated pneumonia

About Actemra®/RoActemra® (tocilizumab)
Actemra/RoActemra was the first humanised 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/RoActemra RA intravenous (IV) clinical development programme included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra/RoActemra RA subcutaneous clinical development programme included two phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. Actemra/RoActemra 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/RoActemra is also approved in the IV formulation for patients two years of age and older with active PJIA, SJIA, GCA, or CAR T cell-induced cytokine release syndrome (CRS). Actemra/RoActemra is not approved for subcutaneous use in people with CRS. It is not known if Actemra/RoActemra 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.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

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