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)

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