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

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  • 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.
Posted In: BiotechNewsHealth CareFDAGeneralBriefsHIV treatment
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