Administration Updates / Coronavirus / Safety & Health

FDA Moving at ‘Lightning Speed’ on Gilead Drug, Hahn Says

FDA

  • Commissioner Hahn says agency wants to see totality of data
  • Several different pathways available for review, Hahn says

The Food and Drug Administration is moving at “lightning speed” to review data on Gilead Sciences Inc.’s experimental Covid-19 treatment remdesivir, Commissioner Stephen Hahn said, after encouraging results emerged from a key U.S. trial.

“We’re working with the company to emphasize the necessity of speed while at the same time to understand the data,” Hahn said in an interview. “There will be a lot of factors that go into all the regulatory decisions. We want to look at the totality of data to make sure that remdesivir is targeted to the right patients.”

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, shared early trial results Wednesday that showed remdesivir had a significant effect in treating the virus. Patients who received the drug recovered from their illness in 11 days, on average, while those who got a placebo recovered in 15 days, Fauci said.

Fauci told NBC’s Today Show on Thursday that a decision on emergency authorization for remdesivir is going to happen “really quickly.” Fauci said he spoke with Hahn Wednesday night and that the FDA hasn’t made a final determination, though he expects one soon.

Hahn declined to offer a timeline for allowing remdesivir to reach the market and said the agency has “several different pathways” through which it could allow access. In addition to emergency authorization, the FDA can speedily approve a medication and then ask for more study while it’s being used by patients.

The FDA has only issued one emergency authorization for a drug to be used against Covid-19. Last month, the agency allowed for use of the malaria drugs hydroxychloroquine and chloroquine in hospitalized patients. Since then, some analyses have shown the pills don’t help and may harm Covid-19 patients. The FDA issued a warning about heart risks associated with those drugs last week.

Hahn said he’s still comfortable with the emergency authorization for hydroxychloroquine and chloroquine and is awaiting data from clinical trials. The decision “was based upon the published data and science available,” he said. “Just as in everything we’ve done in this pandemic, we’ll be flexible and we’ll adapt as data becomes available.”

The FDA has also aimed to be flexible on serology tests that tell people whether they have positive antibodies for the novel coronavirus. The agency has allowed the tests to come to market without its approval, though eight have gained emergency authorization. The National Institutes of Health’s National Cancer Institute is working to ensure the rest work properly and the FDA is reviewing that data as it comes in.

Given that some serology tests may not work as they claim and that some companies that make them haven’t handed over tests for government researchers to evaluate, FDA could consider revising its policy, he said.

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