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FDA Lifts Clinical Hold on Gilead’s HIV Treatment, Lenacapavir
FDA based its decision following a review of Gilead’s data on the storage and compatibility of HIV treatment lenacapavir injection with an alternative vial made from aluminosilicate glass.
FDA recently lifted the clinical hold on Gilead’s investigational new drug application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP).
The agency based its decision following a 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.
In March 2022, FDA first issued a complete response letter (CRL) to Gilead rejecting its new drug application (NDA) for lenacapavir due to chemistry, manufacturing, and controls (CMC) issues relating to the compatibility of lenacapavir.
Specifically, experts questioned the vials of borosilicate glass and their compatibility with the lenacapavir solution. Therefore, FDA placed a clinical hold for lenacapavir in December 2021 due to emerging concerns.
During the hold, screening, patient enrollment, and injectable lenacapavir were not permitted across any studies. But patient monitoring and the dosing of participants in comparator arms and oral formulations of lenacapavir continued.
Following the agency’s most recent decision, all activity can resume in the clinical studies evaluating lenacapavir for HIV treatment and HIV PrEP. And Gilead will work with study site investigators to fully resume the clinical development programs of lenacapavir 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,” Merdad Parsey, MD, PhD, chief medical officer of Gilead, said in the announcement.
“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,” Parsey continued.
In May 2019, FDA granted breakthrough therapy designation for the development of lenacapavir to treat HIV in heavily treatment-experienced patients with multi-drug resistance combined with other antiretroviral drugs.
Additionally, FDA issued a CRL to lenacapavir for its NDA in this population due to vial compatibility. Gilead is working with the FDA to discuss the following steps to use lenacapavir to treat HIV in this population.
