FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP). As previously announced, the FDA had placed a clinical hold on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue. FDA removed the clinical hold following the agency’s review of Gilead’s comprehensive plan and corresponding data on the storage and compatibility of lenacapavir injection with an alternative vial made from aluminosilicate glass.

Following today’s decision from the FDA, all activity can resume in the clinical studies evaluating injectable lenacapavir for HIV treatment and HIV PrEP. During the clinical hold, screening and enrollment of study participants and the dosing of injectable lenacapavir were not permitted across all lenacapavir studies. Other study activities, including the monitoring of participants, the dosing of participants in comparator arms, and the dosing of oral formulations of lenacapavir continued according to the relevant study protocol. Gilead will now work with study site investigators to fully resume the lenacapavir clinical development programs as quickly as possible.

“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, Chief Medical Officer, Gilead Sciences. “Today’s 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.”

In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs. Lenacapavir recently received a complete response letter (CRL) for its new drug application (NDA) in this population due to vial compatibility. Gilead is working with the FDA to discuss next steps for the potential use of lenacapavir for the treatment of HIV in this population. Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS.