Gilead’s Lenacapavir On The Move Again As FDA Lifts Clinical Hold

The long-acting HIV drug’s greatest potential is for pre-exposure prophylaxis, where it would compete against ViiV’s long-acting injectable Apretude.

The FDA has lifted the clinical hold on Gilead's trials of the HIV drug lenacapavir • Source: Shutterstock

Gilead Sciences, Inc. is back in the game to get its long-acting subcutaneous injectable drug for treatment and prevention of HIV onto the market with a green light from the US Food and Drug Administration to resume clinical trials of lenacapavir, enabling the firm to possibly maintain its longtime hold on the pre-exposure prophylaxis (PrEP) market.

Gilead said 16 May that the FDA had lifted the hold on lenacapavir and that all clinical studies of the injectable drug would resume, while the company would also discuss next steps with the agency. The agency placed the hold in December due to a vial compatibility issue, specifically concerns about the borosilicate glass used to produce the vials and the possibility of tiny glass particles forming in the drug solution