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Alkermes' (ALKS) NDA for ALKS 3831 Accepted by FDA for Review

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Alkermes Plc.’s ALKS new drug application (NDA) seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder has been accepted by the FDA for review. The NDA has been given an action date of Nov 15, 2020.

Schizophrenia is a chronic, severe and disabling brain disorder. Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function. 

The NDA for ALKS 3831 includes data from the completed ENLIGHTEN clinical development program in patients with schizophrenia and the pharmacokinetic (PK) bridging data comparing ALKS 3831 with Eli Lilly & Co.’s (LLY - Free Report) Zyprexa (olanzapine).

The NDA includes data to support the treatment of manic or mixed episodes associated with bipolar I disorder, with ALKS 3831 as a monotherapy, or adjunct to lithium or valproate, and the maintenance treatment of bipolar I disorder.

Approval of the additional indication will help Alkermes gain access to a broader patient population.

Shares of Alkermes have slumped 45.6% in the past year compared with the industry’s decline of 5.6%.

We remind investors that in July 2019, after a pre-NDA meeting with the FDA, Alkermes planned to expand the NDA for ALKS 3831 to include the treatment of bipolar I disorder in addition to that of schizophrenia.  In November 2019, the company submitted an NDA to the FDA seeking approval of the candidate for the treatment of both diseases. Alkermes is seeking approval of fixed dosage strengths of ALKS 3831 composed of 10 mg of samidorphan co-formulated with 5 mg, 10 mg, 15 mg or 20 mg of Zyprexa.

Other players in the schizophrenia treatment market include Johnson & Johnson's JNJ Risperdal Consta and Allergan’s AGN Vraylar. Vraylar is also approved for the treatment of adults with major depressive episodes related to bipolar I disorder.

Alkermes currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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