Alkermes schizophrenia drug gets U.S. FDA approval

(Reuters) – Alkermes Plc (ALKS.O) said on Tuesday the U.S. Food and Drug Administration (FDA) had approved its treatment, Lybalvi, for schizophrenia and bipolar I disorder.

The company said it expects to commercially launch the drug in the fourth quarter.

The FDA in November had declined to approve the drug, citing concerns related to a tablet coating process at its manufacturing site.

Lybalvi is a once-daily, oral antipsychotic drug composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity, the company said.

Schizophrenia is a severe mental disorder and affects 20 million people worldwide, according to the World Health Organization.

The company also has FDA-approved antipsychotic and alcohol-dependence treatments in the market.

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Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/alkermes-schizophrenia-drug-gets-us-fda-nod-2021-06-01