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Gilead’s Veklury wins expanded FDA nod for moderate COVID-19 patients despite mixed data

August 31, 2020 Eric Sagonowsky


Amid daily headlines about COVID-19 vaccines and trends, Gilead’s Veklury, also known as remdesivir, remains the only antiviral drug authorized to treat the illness. With a new move from the FDA, the medicine’s emergency green light is a little broader—despite some lingering questions about its efficacy.

Under the expanded emergency use authorization (EUA), all hospitalized COVID-19 patients are eligible for treatment with Veklury. Previously, the drug was restricted for hospitalized patients with severe COVID-19. 

The new authorization comes after phase 3 data showing moderate patients who were on a 5-day course of Veklury, plus standard care, were 65% more likely to have their condition improve compared with patients on standard care alone. For patients on a 10-day course, the chances of improvement weren’t statistically significant. 

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In the wake of those results, experts wrote in an accompanying JAMA editorial that the most suitable patient population for the antiviral is still unclear, and that they’re unsure how long patients should be treated. The authors argued that the latest results were somewhat difficult to interpret, partly because not all patients received a full course. Some patients recovered and were discharged before finishing treatment.

RELATED: Can Gilead’s remdesivir reach moderate COVID-19 patients after mixed data? 

Veklury first won its FDA emergency use authorization back in May. Gilead donated about 120,000 treatment courses to the U.S., and now it’s expecting significant sales revenue in the second half of the year. The company is seeking a full FDA approval in all hospitalized patients.

“As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease,” Gilead’s chief medical officer Merdad Parsey said in a statement. The company is also developing an inhaled version of the intravenous drug in hopes of treating patients who don’t need to be hospitalized.

RELATED: Gilead kicks off clinical trial of inhaled remdesivir for less-severe COVID-19

The FDA’s expanded EUA for Veklury came at the end of a challenging week for the agency. Last Saturday, President Donald Trump accused the regulator of harboring “deep state” employees who are attempting to sabotage the administration’s pandemic response. Commissioner Stephen Hahn denied the allegation in a Reuters interview.

Also last weekend, the agency ran into controversy with its EUA for convalescent plasma. In announcing that move, Hahn said the treatment is associated with a “35% improvement in survival.” The statement was inaccurate, and Hahn has since said he regrets “contributing to any misperception.” 

RELATED: FDA would consider COVID vaccines before phase 3 trials finish, commissioner says 

Moving forward, after the expanded Veklury EUA, attention will likely shift increasingly to vaccine phase 3 trials and potential reviews for approval. Hahn recently told the Financial Times his agency would review applications submitted ahead of phase 3 trial completions if drugmakers submit preliminary data.



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