Gilead Announces FDA Lifts Clinical Hold on Lenacapavir for HIV Treatment and PrEP

On May 16, Gilead Sciences announced that the FDA had lifted the clinical hold on lenacapavir, a new HIV drug for the treatment of HIV and HIV pre-exposure prophylaxis (PrEP).

In December 2021, the FDA placed a clinical hold on all clinical studies of lenacapavir for injection in borosilicate vials. The reason was the FDA's concern about the compatibility of borosilicate glass vials with lenacapavir solution, which might lead to the formation of sub-visible glass particles in the lenacapavir solution.

After reviewing Gilead's comprehensive plan and the storage and compatibility data of lenacapavir solution with aluminosilicate glass vials, the FDA decided to lift its clinical hold.

Lenacapavir is a first-in-class long-acting HIV capsid inhibitor that inhibits HIV-1 replication by interfering with multiple critical steps in the viral life cycle. It has received FDA Breakthrough Therapy designation. If approved, it will become the only HIV treatment drug administered twice a year.