Gilead Virus Drug Is Cleared for Emergency Use by FDA (2)

Gilead Sciences Inc.’s antiviral drug remdesivir was cleared by U.S. regulators for emergency use in Covid-19 patients, becoming the first medication backed by early clinical data to be made available to fight the novel coronavirus.

Remdesivir reduced the time it took hospitalized Covid-19 patients to recover in an interim analysis of an ongoing study.The Food and Drug Administration granted an emergency-use authorization, President Donald Trump said on Friday, a step by which the agency can allow products to be used without full data on their safety and efficacy.

Gilead shares closed down 4.8% on Friday at $79.95 in New York. The company has faced questions from investors about how it plans to make money on the drug, but its stock is still up 23% this year, at a time when the rest of the market has cratered.

“This was lighting speed in terms of getting something approved,” said FDA Commissioner Stephen Hahn, speaking with Trump. “From clinical trial to getting it authorized, it was 90 days.”

Emergency use is limited to hospitalized Covid-19 patients with low blood-oxygen levels or who need breathing support, the FDA said in a statement. A U.S.-led study released this week showed patients given remdesivir, which is administered by an intravenous infusion, recovered in 11 days, on average, while those who got a placebo recovered in 15 days.

Finding a reliable therapy is important for 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. Remdesivir could help curb the coronavirus, which has infected more than a million people in the U.S., and provide a bridge to an effective vaccine.

The FDA has also authorized two malaria drugs, hydroxychloroquine and chloroquine, for use against Covid-19, but those haven’t undergone rigorous research or shown an effect against the coronavirus.

Donating Supply

Gilead is donating 1.5 million doses of remdesivir, its entire current supply, as it continues to seek full FDA approval and clearance from regulators around the world. That would cover 140,000 patients based on a 10-day treatment cycle.

Gilead didn’t comment on what it plans to charge for the medication once the 1.5 million doses have been exhausted.

“Given the severity of illness of patients appropriate for remdesivir treatment and the limited availability of drug supply, hospitals with intensive care units and other hospitals that the government deems most in need will receive priority in the distribution of remdesivir,” Gilead said in a statement.

The medication will be produced by Gilead and the U.S. government will coordinate its distribution.

Patients who are hospitalized and in need of oxygen support account for about 14% of Covid-19 patients, according to early studies of the outbreak. Patients on a mechanical ventilator or heart-lung bypass machine should receive it for 10 days, while those who are less sick should get it for five days, the company said.

Added Scale

Gilead has quickly scaled up manufacturing of remdesivir, which it wasn’t producing in January, by working with multiple partners around the world. It plans to make 500,000 treatment courses by October and double that number by December.

The company is also building a consortium of chemical and pharmaceutical companies to help produce it.

Some investors have asked how, or if, Gilead will make money on the product. Analysts asked on an earnings conference call Thursday 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.”

(Updates with Gilead shares and other details starting in the third paragraph)

--With assistance from Catherine Dodge and Greg Sullivan.

To contact the reporters on this story:
Drew Armstrong in New York at darmstrong17@bloomberg.net;
Justin Sink in Washington at jsink1@bloomberg.net;
Anna Edney in Washington at aedney@bloomberg.net;
Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editors responsible for this story:
Drew Armstrong at darmstrong17@bloomberg.net

Timothy Annett, Mark Schoifet

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