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FDA Lifts Clinical Hold of Lenacapavir for HIV Treatment and Prevention

The FDA lifted a clinical hold on investigational lenacapavir for HIV treatment and pre-exposure prophylaxis. All clinical studies evaluating injectable lenacapavir can now resume.

This week, Gilead Sciences, Inc. announced that the US Food and Drug Administration (FDA) has reinstated the company’s Investigational New Drug (IND) to study injectable lenacapavir for HIV treatment and pre-exposure prophylaxis (PrEP).

The FDA had previously paused lenacapavir in borosilicate vials due to vial compatibility issues. The clinical hold was removed once the FDA reviewed Gilead’s data-backed plan to store injectable lenacapavir in a vial made from aluminosilicate glass.

“We are pleased to have identified an alternative vial for lenacapavir, and to now advance the robust clinical program for this potential first-in-class long-acting option for HIV treatment and prevention,” said Merdad Parsey, MD, PhD, the chief medical officer of Gilead.

With the FDA’s decision, all clinical study activity can resume, including investigations of lenacapavir for treating and preventing HIV. The hold was originally announced on December 21, 2021, and 10 clinical studies were subsequently paused.

During the clinical hold, screening and enrollment of new study participants for lenacapavir trials was not permitted. Participant monitoring, dosing in comparator arms, and dosing of oral formulations were allowed to continue in line with study protocol.

Gilead announced the receipt of a complete response letter (CRL) from the FDA on March 1, 2022, in response to its New Drug Application (NDA) for lenacapavir. The letter cited Chemistry Manufacturing and Controls (CMC) vial compatibility problems as the reason for the clinical hold.

Now, Gilead can work with site investigators to fully resume lenacapavir study and development. Lenacapavir is Gilead’s investigational long-acting HIV-1 capsid inhibitor, intended to treat and prevent HIV infection. Lenacapavir is designed to prevent HIV at multiple stages of its lifestyle, instead of just inhibiting viral replication.

Lenacapavir was originally granted Breakthrough Therapy Designation after the FDA reviewed positive data from the CAPELLA study. This double-blinded, placebo-controlled, global multicenter study evaluates the antiviral activity of lenacapavir in people with severe multidrug-resistant HIV infection.

Gilead Sciences, Inc., is a biopharmaceutical company that has worked in HIV research, treatment, and prevention for 35 years. Gilead investigators have developed 11 HIV medications, including the first single-tablet antiviral regimen for HIV PrEP.