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.
https://www.marketscreener.com/ROCHE-HOLDING-AG-9364975/news/Roche-Genentech-Says-FDA-Approves-Clinical-Trial-for-Actemra-for-Hospitalized-Patients-With-Severe-30213619/
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