Gilead Hit By FDA Complete Response Letter For Lenacapavir In HIV Infection

The FDA has issued a complete response letter (CRL) for Gilead Sciences Inc's GILD application for lenacapavir for heavily treated multi-drug resistant (MDR) HIV-1 infection.
Lenacapavir is an investigational, long-acting HIV-1 capsid inhibitor.
In the CRL, the FDA has cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with the proposed container vial.
The FDA raised questions about vials made of borosilicate glass and their compatibility with the lenacapavir solution, resulting in a clinical hold for injectable lenacapavir.
Gilead intends to provide FDA with a comprehensive plan and corresponding data to use a different vial type.
Related: Gilead's Lenacapavir Shows Sustained Efficacy In Pretreated HIV Patients.
The lenacapavir application was submitted to the FDA to treat heavily-treatment experienced people with multi-drug resistant HIV in June 2021 and selected for priority review.
Price Action: GILD shares are down 0.66% at $60.00 during the market session on the last check Tuesday.

Overview Rating:

Good

100

0100