FDA Accepts Alkermes' New Drug Application Resubmission

Alkermes' schizophrenia and bipolar disorder treatment candidate is once again being reviewed by the FDA.
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Drug maker Alkermes PLC  (ALKS) - Get Report announced Tuesday that the U.S. Food and Drug Administration had accepted the company's resubmission of its new drug application for its treatment for adults with schizophrenia or bipolar 1 disorder. 

The FDA turned away the Dublin-based biopharmaceutical's ALKS 3831 candidate last  month after taking issue with conditions related to the tablet-coating process that was done at the company's plant in Wilmington, Ohio. 

The drug application has a new target action date of June 1, 2021. 

Shares of Alkermes initially jumped on the news but were recently trading down 0.5% to $21.15.

Alkermes said that none of the new FDA requests associated with the acceptance of its resubmission raise any concerns about the clinical or non-clinical data that it has presented. The FDA also has not asked Alkermes to complete any new clinical trials to support approval of its application. 

ALKS 3831 is an investigational, novel, once-daily antipsychotic drug candidate that is taken orally. 

Alkermes said it will continue to work closely with the FDA as it completes its review of ALKS 3831, and that it remains committed to making the treatment available to patients as soon as possible. 

Last month, the company announced a value enhancement plan designed to drive growth and improve its operational and financial performance. 

"These new initiatives also support our strong growth trajectory, which has come more clearly into focus over the past few months, with the positive advisory committee meeting and constructive regulatory interactions for ALKS 3831 for schizophrenia and bipolar I disorder," said CEO Richard Pops. "We believe these actions, alongside our focus on commercial execution, the potential approval and commercial launch of ALKS 3831, and the continued development of our pipeline candidates, position the company well for long-term value creation."