FDA CRL - Gilead Sciences, Inc.

Gilead Sciences, Inc. received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA 215974) for lenacapavir tablet, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. The FDA determined that the application cannot be approved in its present form due to several deficiencies. A primary issue identified was deficiencies in the product quality information for the related lenacapavir injection (NDA 215973), as the approval of the tablet is contingent on the injection's approval. Gilead must submit a letter of authorization referencing the injection's Complete Response submission date.

Further required actions include a comprehensive safety update, which must incorporate new nonclinical and clinical data, detail any significant changes in the safety profile, provide updated tabulations of adverse events, patient discontinuations, and case report forms for deaths or serious adverse events. An updated summary of worldwide safety experience is also required. The FDA reserved comments on proposed prescribing information, carton/container labeling, and the proprietary name (Sunlenca) until other issues are resolved, advising Gilead to review labeling resources and utilize the SRPI checklist for revisions. Additionally, the agency provided recommendations concerning virology data, such as complete resistance data for virologic failures, and clinical assessments, including an evaluation of glass particulate contamination related to injection site reactions. Gilead has one year to resubmit a complete response addressing all identified deficiencies.