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FDA clears remdesivir for emergency use against COVID-19, Trump says

Vials of the drug Remdesivir on display during a news conference about the start of a study with use of the drug in severely ill patients at the University Hospital Eppendorf in Hamburg, Germany, on April 8, 2020, amid the coronavirus pandemic. (Ulrich Perrey/Pool/AFP/Getty Images/TNS)

Gilead Sciences Inc.’s antiviral drug has been cleared by U.S. regulators for emergency use in COVID-19 patients, President Donald Trump told reporters at the White House Friday.

The drug, remdesivir, has shown positive results in helping hospitalized patients recover more quickly. The Food and Drug Administration cleared the drug under an emergency use authorization, a step by which the agency can bring products to market without full data on their safety and efficacy.

Gilead shares closed down 4.8% at $79.95 in New York. The company has faced questions from investors about how it plans to make money on the drug.

FDA Commissioner Stephen Hahn, speaking with Trump, said the drug was being cleared for emergency use in hospitalized patients. A U.S.-led study released this week showed that patients who got the drug recovered in an average of 11 days, while those who get a placebo recovered in 15 days.

An effective therapy against the viral infection is seen as a key bridge between the ongoing outbreak, which has infected more than a million people in the U.S., and longer-term efforts to either stamp out the virus or come up with an effective vaccine. Those measures are all considered crucial by government and health officials to fully reopening the economy and ending social distancing measures that have resulted in millions of lost jobs, closed schools and sent the financial markets through the most turbulent period since the 2008 financial crisis.

Gilead said earlier this week it has about 50,000 courses of the drug ready to distribute. The company has been in talks with the FDA about how the drug will be used, and said it expects the antiviral medication to be a backbone of therapy as well as proof that other drugs can target the virus. It’s also examining how to increase manufacturing of the drug.

It’s also started to face questions about how, or if, it will make money on the product. After reporting quarterly earnings on Thursday, financial analysts on a call with the company asked what its long-term plans were for the drug after it dispenses an early round of the treatment for free.

“There has been no other time like this in the history of the planet,” Chief Executive Officer Daniel O’Day said on the call. “There is no rule book out there, other than that we need to be thoughtful about how we can make sure we provide access of our medicines to patients around the globe and do that in a sustainable way for the company, for shareholders, and we acknowledge that.”


© 2020 Bloomberg News

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