Genentech Says FDA Approves Clinical Trial for Actemra for Hospitalized Patients With Severe Covid-19 Pneumonia

By Michael Dabaie

Genentech, part of Roche, said the U.S. Food and Drug Administration approved a randomized, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority of intravenous Actemra plus standard of care in hospitalized adults with severe Covid-19 pneumonia.

Genentech said it will provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile for potential future use at the direction of the U.S. Department of Health and Human Services. The company said it has business continuity and mitigation strategies in place, and current U.S. supply of Actemra for approved indications isn't expected to be affected.

Genentech said it has also been working with distributors to manage product supply to enable both Genentech and its distribution partners to quickly fill orders to meet patient needs.

Actemra isn't currently approved for this use by the FDA.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

March 23, 2020 10:11 ET (14:11 GMT)

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