Gilead Files US Marketing Application for Remdesivir

By Reuters Staff

August 11, 2020

(Reuters) - Gilead Sciences Inc said on Monday it has filed a marketing application with the U.S. Food and Drug Administration for its experimental COVID-19 drug remdesivir.

The antiviral drug, to be available under the brand name Veklury, is one of the few treatments to have shown to be effective against the respiratory illness.

The treatment has got the U.S. health regulator's approval for emergency use in hospitalized patients with severe COVID-19.

The marketing application is supported by data from two late-stage human trials conducted by Gilead and another late-stage trial by the National Institute of Allergy and Infectious Diseases, the company said.

The drug has been at the forefront in the fight against the respiratory illness after the intravenously administered medicine helped shorten hospital recovery times in a U.S. trial.

Remdesivir has been approved by multiple regulatory authorities around the world, including in the European Union and Japan.

On Friday, Pfizer Inc said it had signed a multiyear agreement to make remdesivir for Gilead Sciences, which is under pressure to increase tight supplies of the antiviral drug.

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