Gilead Again Seeks HIV Drug Approval From FDA After Addressing Vial Compatibility Issues

Gilead Sciences GILD resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection.

Earlier, in the month of February, 2022, the regulatory agency has issued a complete response letter, indicating Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir in borosilicate vials.

The company said that the NDA resubmission addressed issues related to vial compatibility.

Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, said, “There are people with HIV who have severely limited treatment options due to resistance to multiple antiretroviral therapy classes. We are committed to addressing unmet needs and recognize the urgency for filling the critical treatment gap for people with multi-drug resistant HIV whose virus is no longer effectively responding to their current therapy."

The FDA is expected to establish a new Prescription Drug User Fee Act (PDUFA) date, once the New Drug Application (NDA) is accepted for review.

Gilead Shares are trading low at $62.50 during after hour session.