Gilead Sciences on Monday applied for approval from the U.S. Food and Drug Administration for its COVID-19 treatment, remdesivir. The biotech company also said the antiviral drug will go by the Veklury brand name in the US
“Submitting today is a major milestone as we continue to work with the U.S. government and health authorities around the world to address the treatment needs of COVID-19 patients,” said Merdad Parsey, chief medical officer. officer of Gilead, in a statement.
Remdesivir is available in the US on an emergency basis for patients in hospital with serious cases of COVID-19, but FDA approval of Gilead’s new drug application would pave the way for a wider use of the treatment. Remdesivir is already approved for use in Europe and Japan.
The move to secure FDA approval of brake derivatives comes nearly two months after Gilead announced positive results in a Phase 3 trial of the drug, which works by blocking the virus from replicating. That study, conducted by the National Institute of Allergy and Infectious Diseases, was the second encouraging test of the drug. An earlier trial in the U.S. and Europe, which involved more than 1,000 hospital patients, showed that treatment reduced recovery time for COVID-19 patients by nearly a third.
“Since the beginning of the pandemic, Gilead has worked hard to establish Veklury’s efficacy and safety profile, and we now have a robust dataset that supports the evaluation of the use of medicines across a variety of hospital COVIDs. 19 patient populations, ”Parsey said.
Gilead is best known for his treatments for HIV and hepatitis. The share price of Gilead Sciences went up as much as 30% earlier this year. But their shares have fallen more recently as a growing number of drug companies announce they are working on vaccines and other treatments to stop the spread of the coronavirus. The share is now just above 7% up in 2020.
“Remdesivir is not a game changer, but it is a positive,” said Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner at the U.S. Food and Drug Administration. CBS MoneyWatch in April.
Last week, Goldman Sachs predicted in a report that the FDA will approve it at least one vaccine against coronavirus at the end of the year.
Aimee Picchi provided reporting for this story.
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