Alkermes, Inc. – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Alkermes, Inc. for its New Drug Application (NDA 213378) for Lybalvi (olanzapine and samidorphan), submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The application cannot be approved in its current form due to several deficiencies.

A primary issue involves product quality, specifically objectionable conditions identified at Alkermes' Wilmington, OH manufacturing facility (FEI: 10001442940) during a review of records requested under section 704(a)(4). Satisfactory resolution of these manufacturing issues, potentially requiring a preapproval inspection and adequate facility responses, is mandatory for approval.

Additional concerns include the proposed prescribing information, for which comments are reserved until other deficiencies are addressed, and issues with carton and container labeling, specifically a lack of prominence for a 'C' symbol. While the proprietary name, Lybalvi, was deemed acceptable, it must be resubmitted with the complete response.

Alkermes is also required to provide a comprehensive safety update, incorporating all new nonclinical and clinical study data, detailed adverse event reporting, updated exposure information, and a summary of worldwide safety experience. Alkermes must address all identified deficiencies and resubmit the application within one year. The company may request a meeting with the FDA to discuss the required steps for approval.