Alkermes says FDA accepts ALKS 3831 NDA for review, assigns Nov. 15 PDUFA date
Alkermes (ALKS) announced that the U.S. Food and Drug Administration has accepted for review the company’s New Drug Application, or NDA, seeking approval of ALKS 3831 for the treatment of schizophrenia and for the treatment of bipolar I disorder.
ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain.
The NDA has been assigned a Prescription Drug User Fee Act, or PDUFA, target action date of Nov. 15, 2020.
“The acceptance of the NDA for ALKS 3831 marks an important milestone toward our goal of offering a new treatment option to people living with schizophrenia or bipolar I disorder. The ALKS 3831 development program builds on Alkermes’ commitment to developing new therapeutic options that seek to address unmet needs of patients in large therapeutic areas. We believe ALKS 3831 has the potential to be a meaningful new offering for patients with these serious and complex mental health disorders, and we look forward to engaging with the FDA throughout the NDA review process,” said Craig Hopkinson, M.D., Chief Medical Officer at Alkermes.
Alkermes plc researches, develops, and commercializes pharmaceutical products to address unmet medical needs of patients in various therapeutic areas in the United States, Ireland, and internationally.
To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.
This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.