Gilead Sciences Files for FDA OK for Covid-19 Treatment Veklury
August 10 2020 - 11:47AM
Dow Jones News
By Colin Kellaher
Gilead Sciences Inc. on Monday said it filed a new drug
application with the U.S. Food and Drug Administration for Veklury,
known generically as remdesivir, for the treatment of patients with
Covid-19.
The antiviral medication is currently available in the U.S.
under an emergency-use authorization for the treatment of
hospitalized patients with severe Covid-19.
The Foster City, Calif., biopharmaceutical company said the FDA
filing is the final tier of the rolling NDA submission that it
began in April.
Gilead said the filing is supported by data from phase 3 studies
that showed treatment with Veklury led to faster time to recovery
compared with placebo, and that a 5-day or 10-day treatment
duration led to similar clinical improvement.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 10, 2020 11:32 ET (15:32 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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