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Gilead Gains Expanded FDA Authorization for COVID-19 Treatment Remdesivir

By Brian Orelli, PhD – Aug 28, 2020 at 8:01PM

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The drug can now be used by hospitalized patients with moderate COVID-19.

Gilead Sciences (GILD -0.19%) gained expanded emergency use authorization from the Food and Drug Administration for its COVID-19 treatment remdesivir, which now goes by the brand name Veklury.

The previous authorization covered hospitalized patients with severe COVID-19. The new indication includes "all hospitalized patients with COVID-19," expanding the use to patients with moderate forms of the disease who are still sick enough to require hospital care.

The expanded authorization is based on results from a phase 3 clinical trial run by Gilead called the SIMPLE study. Patients with moderate COVID-19 treated with the drug for five days were 65% more likely to have an improvement in their clinical status at day 11 compared to patients who didn't get the drug at all.

The authorization was also supported by ACTT-1, a clinical trial testing the drug in hospitalized patients with a range of disease severities that was run by the National Institute of Allergy and Infectious Diseases.

Doctors in personal protective equipment and a patient behind a glass door with a sign that reads caution: outbreak alert.

Image source: Getty Images.

The emergency use authorization allows Gilead to sell Veklury during the pandemic, but the drugmaker will have to gain additional FDA approval if it wants to market Veklury after the public health emergency ends.

It remains to be seen how much the expanded authorization will help Gilead. There are currently more patients who need the drug than doses available, so expanding the authorization doesn't really help Gilead in the immediate term.

Gilead has taken steps to boost production. Earlier this month, Gilead partnered with Pfizer (PFE 1.07%) to help manufacture Veklury at Pfizer's McPherson, Kansas plant. Terms of the deal, including volume and pricing, weren't disclosed, so it's unclear exactly how much the added manufacturing capability will benefit Gilead's bottom line. But like today's expanded authorization, the expanded production is ultimately a boon to patients infected with COVID-19, and it should also benefit Gilead in the long term.

Brian Orelli, PhD has no position in any of the stocks mentioned. The Motley Fool owns shares of and recommends Gilead Sciences. The Motley Fool has a disclosure policy.

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