FDA green light for Lybalvi in schizophrenia and bipolar 1 disorder

2 June 2021

The US Food and Drug Administration has approved Lybalvi (olanzapine and samidorphan; ALKS-3831) for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate, Ireland-incorporated Alkermes (Nasdaq: ALKS) announced on Tuesday, when the firm’s shares rose as much as 7% to $24.28.

Lybalvi is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity. Olanzapine is the active ingredient of Eli Lilly’s (NYSE: LLY) Zyprexa.

Alkermes, which suffered a setback in its development of the combo drug last year when the FDA issued a Complete Response Letter (CRL) relating to manufacturing issues, expects to make Lybalvi available for patients in the fourth quarter of 2021.

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