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

NEW YORK (Capital Markets in Africa) — 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 while requiring additional study once it’s on the market.

Source: Bloomberg Business News