FDA granted Emergency Use Authorization for Roche’s Actemra/RoActemra in June last year.
The US Food and Drug Administration (FDA) has given priority evaluation of Roche's Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults, according to Roche. Actemra/RoActemra is a humanized interleukin-6 (IL-6) receptor antagonist that is now approved to treat adults with moderately to severely active rheumatoid arthritis (RA). The treatment is for COVID-19 adult patients who are hospitalized and require supplementary oxygen while on systemic corticosteroids. "If approved, Actemra/RoActemra would be the first U.S. FDA-approved immunomodulator for the treatment of COVID-19 in hospitalized patients," Roche said in a statement, adding that more than 1 million people hospitalized with COVID-19 had been treated with Actemra/RoActemra worldwide since the beginning of the pandemic.
Roche expects the regulatory authorities to make a decision on approval in the second half of this year. The application was based on the results of four randomized, controlled clinical trials that evaluated Actemra/RoActemra for the treatment of COVID-19 in over 5,500 hospital patients. Actemra/RoActemra, which is also approved in 16 countries worldwide for severe or critical Covid-19 patients in the hospital, received Emergency Use Authorization from the FDA in June of last year. "Actemra/RoActemra has already been used to treat more than one million people with severe or serious Covid-19 around the world, indicating the essential role this medicine plays in the battle against the pandemic."