Roche gets USFDA priority review for Actemra to treat Covid-19
Basel: Roche today announced that the U.S. Food and Drug Administration (USFDA) 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.
In June 2021, Actemra/RoActemra received Emergency Use Authorization from the U.S. FDA and is currently approved for use in 16 countries around the world for defined patients hospitalised with severe or critical COVID-19. In February 2022, the World Health Organization (WHO) prequalified Actemra/RoActemra for patients with severe or critical COVID-19, supporting access to care in low- and middle-income countries.
In addition to working with health authorities, Roche has established a comprehensive access approach to improve availability of its COVID-19 medicines around the world including:
- 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.
- Implementing an international differentiated pricing strategy specifically designed to address needs during this pandemic and improve affordability.
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.
Actemra/RoActemra is approved for use in multiple territories including the European Union, Japan, Bolivia, Chile, Guatemala, Ecuador, Honduras, Hong Kong, Myanmar, Peru, Philippines, the United Kingdom and Ukraine, provisionally approved in Australia, and authorised for emergency use in Ghana, Korea and the United States for defined patients hospitalised with severe or critical COVID-19. It has also been recommended and prequalified by the World Health Organization.
Read also: Roche gets WHO prequalification for Tocilizumab to treat severe COVID-19
