FDA accepts Alkermes' ALKS 3831 NDA resubmission

 

• Alkermes (ALKS) announces that the FDA has acknowledged receipt of its New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder,
• The FDA has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021.
• The FDA classified the resubmission as a complete, class 2 response to the Complete Response Letter (CRL) issued in November 2020.
• Neither the CRL nor this subsequent records flagged any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application.
• Alkermes will continue to work closely with the FDA as it completes its review of the ALKS 3831 NDA and remains committed to making the treatment available to patients as quickly as possible.
• Earlier this month, the company announced a strategic plan to achieve FY 2023 EBITDA margin rate of 20%.
• https://seekingalpha.com/news/3647651-fda-accepts-alkermes-alks-3831-nda-resubmission