Gilead seeks FDA approval for COVID-19 drug remdesivir
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 brand name of Veklury in the U.S.
"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," said Merdad Parsey, Gilead's chief medical officer, in a statement.
Remdesivir is available in the U.S. on an emergency basis for hospitalized patients with severe cases of COVID-19, but FDA approval of Gilead's new drug application would clear the way for wider use of the treatment. Remdesivir has already been approved for use in Europe and Japan.
The move to secure FDA approval of remdesivir 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, that involved over 1,000 hospitalized patients, showed that the treatment reduced recovery time for COVID-19 patients 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.
Gilead is known chiefly for its HIV and hepatitis treatments. Gilead Sciences stock price surged as much as 30% in the early stages of the pandemic earlier this year. But its 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 stock is now up just over 7% in 2020.
"Remdesivir isn't a game changer, but it is a positive," Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner with the U.S. Food and Drug Administration, told CBS MoneyWatch in April.
Last week, Goldman Sachs predicted in a report that the FDA will approve at least one coronavirus vaccine by the end of the year.
Aimee Picchi provided reporting for this story.