Gilead Sciences has announced the US Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s investigational new drug application (IND) for injectable lenacapavir. The drug is intended to be used for treatment and pre-exposure prophylaxis (PrEP) of HIV.
The agency had placed a clinical hold on the use of injectable lenacapavir in borosilicate vials after the emergence of a vial compatibility issue. It removed the clinical hold after its review of Gilead’s plan and corresponding data on the storage and compatibility of lenacapavir injection with an alternative 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, chief medical officer of 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.”
With the FDA’s decision to remove the hold, activity can resume in the clinical studies evaluating injectable lenacapavir for HIV treatment and HIV PrEP. During the hold, screening and enrollment of study participants and the dosing of injectable lenacapavir were barred across all lenacapavir studies; other study activities (including monitoring participants, dosing participants in comparator arms, and dosing of oral formulations of lenacapavir) continued according to the relevant study protocol.
According to Gilead representatives, the pharmaceutical company will now work with study site investigators to resume the lenacapavir clinical development programs as quickly as possible.
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 reportedly is working with the FDA on determining the appropriate next steps for the potential use of lenacapavir for the treatment of HIV in this population. Lenacapavir is an investigational compound, and it is currently not approved by any regulatory authority for any use and its safety and efficacy are not established.