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Gilead Announces Clinical Hold on Studies Evaluating Injectable Lenacapavir for HIV Treatment and Prevention Due to Vial Quality Concerns
-- Pause Due to Concerns About Compatibility of the Vial Type with the Drug Solution -- FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq:
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n-- Pause Due to Concerns About Compatibility of the Vial Type with the Drug Solution --\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and HIV pre-exposure prophylaxis (PrEP). The FDA’s clinical hold is due to emerging concerns about the compatibility of vials made of borosilicate glass with lenacapavir solution, which could potentially lead to the formation of sub-visible glass particles in the solution of lenacapavir. Dosing of oral formulations of lenacapavir will continue. The company remains confident about the future potential of lenacapavir and is committed to resolving this vial quality issue.\n\nDuring 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 the monitoring of participants and the dosing of participants in comparator arms, will continue according to the relevant study protocol.\n\n“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, MD, PhD, Chief Medical Officer, Gilead Sciences.\n\nThe following studies have been placed on clinical hold:\n\n\n\nStudy\n\n\n\nPhase\n\n\n \n\n\n\nTitle\n\n\n\n\n\nGS-US-200-4625\n\n\n\nPhase 2/3\n\n\n(NCT 04150068)\n\n\n\nA Phase 2/3 Study to Evaluate the Safety and Efficacy of Long Acting Capsid Inhibitor GS-6207 in Combination with an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection with Multidrug Resistance\n\n\n\n\n\nGS-US-200-4334\n\n\n\nPhase 2\n\n\n(NCT 04143594)\n\n\n\nA Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination with Other Antiretroviral Agents in People Living with HIV\n\n\n\n\n\nGS-US-200-5709\n\n\n\nPhase 1\n\n\n\nA Phase 1 Study in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Lenacapavir (LEN)\n\n\n\n\n\nGS-US-412-5624\n\n\n\nPhase 3\n\n\n(NCT 0499...