Former FDA Commissioner Says Gilead's Remdesivir Could Have Enough Data For Emergency Use Authorization

Former FDA Commissioner Dr. Scott Gottlieb spoke on CNBC Thursday about Gilead's GILD remdesivir trial.

Enough data is likely accumulated at this point that the regulatory agency might consider making the drug available under the emergency use authorization or through accelerated approval, Gottleib sad. 

A randomized study conducted by the National Institute of Allergy and Infectious Diseases is now probably fully enrolled and could serve as a pivotal study in order to tell how efficacious the drug is, he said.

Remdesivir is probably not a home run and probably not a cure, but it is probably something that could be used when patients have early symptoms and can likely be effective in mitigating a bad outcome for a number of patients, Gottleib said. 

The information collected so far suggests that the drug is active, but it is not optimal by any means, the former FDA commissioner said. 

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The drug's issues include the fact that it has to be given intravenously; supply is going to be an issue; it is hard to manufacture; and there are issues with liver malfunction, which manifests through elevated liver enzymes, he said.

The liver issues are self-correcting in most cases, Gottleib told CNBC. 

In settings like the coronavirus pandemic, where drugmakers are developing therapeutics for a virus, the initial drugs are often imperfect, but they work, he said. 

Remdesivir was tried with Ebola and SARS, and the drug has an accumulated safety database, he said. 

Gilead shares were trading 9.35% higher at $83.70 at the time of publication in Friday's premarket session.