Benzinga | Dec 22, 2021 08:14AM EST

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

* The FDA has placed a clinical hold on Gilead Sciences Inc's (NASDAQ: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.