Complete Response Letter from FDA for investigational lenacapavir due to vial compatibility issues.
Gilead Sciences, Inc. the FDA has issued a complete response letter (CRL) for the New Drug Application (NDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor under review for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.
In the CRL, the FDA has cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with the proposed container vial as the reason for their action. As previously announced, FDA raised questions about vials made of borosilicate glass and their compatibility with lenacapavir solution, which has resulted in a clinical hold for injectable lenacapavir.
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