U.S. FDA grants priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults

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The FDA has given Priority Review for Actemra/RoActemra (tocilizumab) intravenous 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, according to Roche. The FDA in the United States is scheduled to make a decision in the second part 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. 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,”

said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development, Roche.

The sBLA submission is based on the findings of four randomized, controlled studies in which Actemra/RoActemra was examined for the treatment of COVID-19 in over 5,500 hospitalized patients. Overall, the findings of these four studies (EMPACTA, COVACTA, REMDACTA, and RECOVERY) imply that Actemra/RoActemra may help patients who are on corticosteroids and need supplementary oxygen or breathing support.

Actemra/RoActemra gained Emergency Usage Authorization from the US Food and Drug Administration in June 2021, and it is now licensed for use in 16 countries for specific patients hospitalized with severe or critical COVID-19.6,7 The World Health Organization (WHO) prequalified Actemra/RoActemra for patients with severe or critical COVID-19 in February 2022, allowing low- and middle-income countries easier access to treatment.

Roche has developed a comprehensive access approach to improve the availability of its COVID-19 medicines around the world in addition to collaborating with health authorities, which includes:

Providing Actemra/RoActemra to WHO and partners of the Access to COVID-19 Tools Accelerator (ACT-A) Initiative at no cost, building on Roche’s large supply of Actemra/RoActemra to upper-middle- and lower-middle-income countries since the pandemic began.

Implementing a global differentiated pricing plan that is specially tailored to meet the requirements of those affected by the epidemic while also improving affordability.

Following the discovery of the SARS-CoV-2 variation of concern, Omicron (B.1.1.529), WHO indicated in December 2021 that interleukin-6 receptor blockers, such as Actemra/RoActemra, are still predicted to be helpful in the treatment of individuals with severe COVID-19.

Roche stands in solidarity with society, governments, healthcare providers, and everyone else trying to end the COVID-19 pandemic.

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