FDA places clinical hold on use of injectable lenacapavir for HIV treatment

pharmafile | December 22, 2021 | News story | Research and Development  

The 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 injectable treatment is manufactured by biopharmaceutical company Gilead Sciences.

The clinical hold is based on emerging concerns about the compatibility of the vials, which are made of borosilicate glass with lenacapavir solution. This combination could potentially lead to the formation of non-visible glass particles in the solution of lenacapavir. Dosing of oral formulations of lenacapavir will continue, while Gilead seeks to resolve this vial quality issue.

As part of the clinical hold, screening and enrolment of study participants, and the dosing of injectable lenacapavir, will be halted across all lenacapavir studies. However, 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.

“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.

Lenacapavir is Gilead’s potential first-in-class, investigational, long-acting HIV-1 capsid inhibitor, in development for the treatment and prevention of HIV-1 infection. It is designed to provide a new treatment option for the development of long-acting therapy options for people living with, or at risk of, HIV-1. While many current antivirals act on only one stage of viral replication, lenacapavir works to inhibit HIV-1 at multiple stages of its lifecycle.

Lina Adams

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