FDA Gives Remdesivir the Go-Ahead for Emergency Use

The FDA on Friday granted Gilead’s remdesivir an Emergency Use Authorization (EUA) as a COVID-19 treatment, based on positive results from two clinical trials.

Under the EUA, the antiviral will be administered intravenously to treat suspected or laboratory-confirmed COVID-19 in adults and children with low blood oxygen levels or needing oxygen therapy or more intensive-breathing support.

Gilead is hyper-focused on making remdesivir work for COVID-19. The company has committed to donating its current supply of 1.5 million doses for clinical trial and emergency use.

And in a first-quarter earnings report call with investors on Thursday, CEO Daniel O’Day said that the company is looking into developing the drug in inhaled or subcutaneous formulations.

“Although it’s too premature to give you timelines on that, rest assured we’ve been actively working on them. We’ll continue to pursue those with a great sense of urgency,” he said.

He did, however, dismiss the possibility of developing an oral formulation. “This particular medicine ... is not really appropriate as an oral formulation. We’ve known that for years, probably a decade,” he said.

In related news, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has begun a “rolling review” of remdesivir for COVID-19, aimed at cutting its review time from months to weeks.

The CHMP will appoint leaders to review the drug while it is still under development. The EMA normally requires trial data to be available at the start of an evaluation.

The agency noted the positive results from a National Institutes of Health clinical trial of the antiviral drug, but said it is too early to draw any conclusions (DID, April 30).

Under the rolling review process, the agency will review clinical data about remdesivir as it becomes available. Each review cycle is expected to take approximately two weeks.

The EMA did not specify a timeline for reviewing a marketing authorization application from Gilead, but said it expects to complete its assessment “significantly earlier” than it would using the normal evaluation procedure.

The rolling review process was established during the 2014 Ebola outbreak to quickly evaluate treatments and vaccines. It has not been used since then. — Jordan Williams