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Alkermes' Lybalvi gains FDA approval for schizophrenia, bipolar I disorder

Alkermes announced Tuesday the US approval of Lybalvi (olanzapine/samidorphan) for the treatment of adults with schizophrenia and bipolar I disorder. Specifically, the once-daily, oral drug is indicated as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate.

Lybalvi, which is expected to be launched in the fourth quarter, combines the established antipsychotic agent olanzapine and the new chemical entity samidorphan. The fixed-dose therapy is designed to provide the effectiveness of olanzapine, whilst reducing the drug's side effects, including weight gain.

June 1st, 2021

https://www.firstwordpharma.com/

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