Gilead files US marketing application for remdesivir
The treatment has got the U.S. health regulator’s approval for emergency use in hospitalized patients with severe COVID-19
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.
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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.
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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.