Genentech Says FDA Approves Clinical Trial for Actemra for Hospitalized Patients With Severe Covid-19 Pneumonia
March 23 2020 - 10:26AM
Dow Jones News
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 michael.dabaie@wsj.com
(END) Dow Jones Newswires
March 23, 2020 10:11 ET (14:11 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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