Roche upgraded its emergency use authorization for Actemra in certain hospitalized Covid-19 patients to a full FDA approval, the company announced Wednesday, as cases climb in the US.
The approval comes roughly six months after the monoclonal antibody treatment received an EUA to treat hospitalized patients 2 years and older who are also receiving systemic corticosteroids and require supplemental oxygen, ventilation or life support. While the approval is only for adults, Actemra will continue to be available for younger patients under the EUA.
Levi Garraway“With new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19,” Levi Garraway, head of global product development at Roche’s Genentech, said in a news release.
Actemra was first approved by the FDA in 2010 to treat moderately to severely active rheumatoid arthritis. It’s since snapped up a long list of clearances, including as an immunosuppressant and in various subcutaneous formulations. It was authorized in June for Covid patients, and weeks later the World Health Organization endorsed the use of the IL-6 class, which also includes Sanofi’s Kevzara, for severe cases. Roche announced that the FDA accepted its supplemental biologics license application (sBLA) for Actemra in Covid-19 back in April.
Actemra is already approved in more than 30 countries for hospitalized patients with severe Covid, according to Roche, and more than a million Covid patients have been treated worldwide.
Covid continues to rise in some parts of the US, as the Omicron BQ.1 and BQ.1.1 variants represent nearly 70% of cases in the country, according to the CDC’s variant tracker.
The FDA has pulled a handful of other monoclonal antibody treatments from the market that specifically targeted the virus. Those withdrawals were “due to the high frequency of variants circulating within the United States that are not susceptible” to the medicines, which include Regeneron’s REGEN-COV, GSK’s Xevudy and Eli Lilly’s bamlanivimab and etesevimab as of last month.
