- The FDA has issued a complete response letter (CRL) for Gilead Sciences Inc's (NASDAQ: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.
