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Gilead Seeks FDA Approval for Remdesivir

TUESDAY, Aug. 11, 2020 -- Gilead Sciences has applied to the U.S. Food and Drug Administration for approval for its COVID-19 treatment, remdesivir. The antiviral drug will take the brand name Veklury, the company said.

"Today's filing is an important milestone as we continue to partner with the U.S. government and health care authorities around the globe to address the treatment needs of patients with COVID-19," Merdad Parsey, M.D., Ph.D., Gilead's chief medical officer, said in a statement.

At the moment, remdesivir is available on an emergency basis for hospitalized patients with severe COVID-19. If the FDA approves it, however, the drug will gain wider use. Remdesivir is already approved in Europe and Japan. The request for approval comes after the results of a phase 3 trial. The drug works by blocking the virus from copying itself. Trials of the drug showed that it can cut recovery time from COVID-19 by nearly a third.

"Since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of Veklury, and we now have a robust data set supporting the evaluation of use of the drug across a range of hospitalized COVID-19 patient populations," Parsey said.

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