FDA Slaps Clinical Hold On Gilead's Injectable Lenacapavir In HIV Trials

The FDA has placed a clinical hold on Gilead Sciences Inc's GILD injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and pre-exposure prophylaxis (PrEP).
The FDA's clinical hold is due to emerging concerns about the compatibility of borosilicate glass-made vials with lenacapavir solution, which could lead to the formation of sub-visible glass particles in the solution of lenacapavir.
The hold will impact ten lenacapavir trials, either monotherapy or combination.
Related: Gilead, Merck Stop Enrollment In Mid-Stage HIV Combination Therapy Trial.
Dosing of oral formulations of lenacapavir will continue.
During the clinical hold, screening and enrollment of study participants and the dosing of injectable lenacapavir will not be permitted across all lenacapavir studies.
All other study activities, including monitoring participants and the dosing of participants in comparator arms, will continue according to the relevant study protocol.
"We are committed to working diligently with FDA to resolve this glass vial compatibility quality issue and resume injectable lenacapavir dosing in the affected studies in a timely fashion," said Merdad Parsey, Chief Medical Officer, Gilead Sciences.
Price Action: GILD shares are down 0.22% at $71.68 during the premarket session on the last check Wednesday.