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Gilead Sciences Announced FDA Acceptance of New Drug Application for Investigational Lenacapavir fro HIV=1 Infection

Gilead Sciences today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) resubmission for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection i...

Benzinga · 07/28/2022 05:05
Gilead Sciences today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) resubmission for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 27, 2022. Gileadresubmitted the NDAon June27, 2022. Theresubmissioncontained comprehensive Chemistry Manufacturing and Controls (CMC) data to support the compatibility oflenacapavirwith an alternative vial type made from aluminosilicate glass.The NDA isalsosupportedbydata from the Phase 2/3 CAPELLA study, whichevaluated the antiviral activity oflenacapaviradministered every six months as a subcutaneous injection, in combination with other antiretroviral(s),in heavily treatment-experienced people with multi-drug resistant HIV-1 infection.The submission includesextensive pre-clinical and earlier clinical research data as well. "Lenacapavir has the potential as an important breakthrough innovation to be transformative for people with multi-drug resistant HIV whose virus is no longer effectively responding to their current therapy," said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. "This regulatory milestone moves us one step closer to providing an innovative treatment option that could meet the unmet needs of people who have severely limited therapy choices." The FDA's acceptance of the NDAresubmission as a complete responseis the latest milestone in the review oflenacapavirby a major regulatory authority. The European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) recently adopted apositive opinionin its review of lenacapavir. The final European Commission decision is expected later this year.Additional regulatory filings are anticipated to continue throughout 2022. Lenacapaviris an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS.