Gilead Sciences Resubmits NDA to FDA for Lenacapavir
Gilead Sciences today announced the resubmission of 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 in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.
Gilead resubmitted the NDA in response to the FDA Complete Response Letter (CRL) issued in February 2022, which cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir in borosilicate vials as the reason for the FDA action. The NDA resubmission contains comprehensive CMC data to support the compatibility of lenacapavir with an alternative vial type made from aluminosilicate glass. In addition, the NDA is supported by extensive pre-clinical and earlier clinical research data as well as data from the Phase 2/3 CAPELLA study, which evaluated the antiviral activity of lenacapavir administered 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.
Once accepted by the FDA, a new Prescription Drug User Fee Act (PDUFA) date will be established.
"There are people with HIV who have severely limited treatment options due to resistance to multiple antiretroviral therapy classes," said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. "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."
Lenacapavir is 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.
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