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FDA approves Alkermes’ Lybalvi for schizophrenia and bipolar I disorder

June 2, 2021


Lybalvi (olanzapine and samidorphan) has been authorised as maintenance monotherapy of adults with schizophrenia or bipolar I disorder, for the acute treatment of manic or mixed episodes and as monotherapy or an adjunct to lithium or valproate.

In clinical trials, Lybalvi demonstrated antipsychotic efficacy, safety and tolerability, including statistically significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.

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