The US Food and Drug Administration (FDA) has removed the clinical hold on Gilead Sciences’ Investigational New Drug Application (IND) of injectable lenacapavir for treating and preventing human immunodeficiency virus (HIV) infection.
An investigational long-acting HIV-1 capsid inhibitor, lenacapavir is intended to hinder HIV-1 at various stages of its lifecycle.
In December last year, FDA put a hold on the usage of injectable lenacapavir in borosilicate vials in all clinical trials underway for HIV treatment and pre-exposure prophylaxis (PrEP).
The clinical hold was attributed to rising concerns about the compatibility of borosilicate glass vials with lenacapavir.
The latest development comes after the regulatory agency analysed the company’s complete plan and related data on the storage and compatibility of lenacapavir with an alternative vial that is made of aluminosilicate glass.
With the lifting of the clinical hold, all works in the clinical trials assessing injectable lenacapavir to treat and prevent HIV can resume.
Screening, subject enrolment and dosing with injectable lenacapavir were not allowed in all the trials of the therapy during the clinical hold.
Meanwhile, other trial operations, including subject monitoring, dosing of volunteers in comparator groups and dosing with oral formulations of lenacapavir, progressed as per the relevant trial protocol.
The company will collaborate with trial site investigators to restart the lenacapavir clinical development programmes soon.
Gilead Sciences chief medical officer Merdad Parsey said: “We are pleased to have identified an alternative vial for lenacapavir and to now advance the robust clinical programme for this potential first-in-class long-acting option for HIV treatment and prevention.
“The news brings us one step closer to our goal of offering therapeutic options for the diverse communities affected by HIV as we work to end the epidemic for everyone, everywhere.”