FDA Lifts Clinical Hold on Gilead's HIV Drug Lenacapavir

A few days ago, Gilead said that the FDA has released its clinical trials of injectable lenacapavir for HIV treatment and pre-exposure prophylaxis will resume.

As early as last December, the FDA first suspended clinical trials related to Gilead's injectable HIV drug candidate lenacapavir.

In response, in March this year, the US FDA issued a complete response letter (CRL) for Gilead's HIV drug lenacapavir marketing application. In the CRL, the FDA pointed to chemical manufacturing control (CMC) issues related to the compatibility of lenacapavir injection with the intended glass vial. The FDA has raised questions about the compatibility of borosilicate glass vials with lenacapavir injection, an issue that has led to the suspension of at least 10 clinical trials of lenacapavir injection.

After receiving the CRL, Gilead said it will provide the FDA with plans and data on the use of different types of vials. At the time, Baird & Co. analysts wrote in a note to clients that the launch of lenacapavir could be delayed by a year due to the FDA decision.

For Gilead, lenacapavir has been one of its blockbuster drugs. The drug is a long-acting HIV-1 capsid inhibitor that inhibits HIV-1 replication by interfering with multiple important steps in the viral life cycle, including capsid-mediated uptake of HIV-1 proviral DNA, viral Assembly and release and formation of the capsid core have received FDA breakthrough therapy designation. If approved, it would be the only HIV treatment to be administered twice a year, much less frequently than currently available drugs.

Previously, investment bank Mizuho Securities said industry analysts agreed that lenacapavir sales could exceed $1.1 billion by 2030.

For now, the FDA has removed its clinical hold after reviewing Gilead's bid to store the drug in an alternative vial made of aluminosilicate glass. Gilead said it will work with investigators at the study site to fully resume the lenacapavir development project as soon as possible.