Gilead seeks FDA approval for COVID-19 drug remdesivir


Gilead Sciences sought approval from the U.S. Food and Drug Administration on Monday for its COVID-19 treatment, remdesivir. The biotech company also said the antiviral drug would carry the brand name Veklury in the United States.“Today’s filing is an important milestone as we continue to partner with the US government and health authorities around the world to meet the treatment needs of patients with COVID-19,” said Merdad Parsey, Gilead’s chief medical officer, in a statement.

Remdesivir is available in the United States on an emergency basis for hospital patients with severe cases of COVID-19, but FDA approval of Gilead’s new drug application would pave the way for wider use of the treatment. Remdesivir has already been approved for use in Europe and Japan.

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The decision to get FDA approval for remdesivir comes nearly two months after Gilead announced positive results in a Phase 3 trial of the drug, which works by blocking replication of the virus. The study, conducted by the National Institute of Allergy and Infectious Diseases, was the drug’s second encouraging test. A previous trial in the United States and Europe, which involved more than 1,000 inpatients, showed that treatment reduced recovery time for COVID-19 patients by nearly a third.


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