FDA approves Lybalvi for schizophrenia and bipolar I disorder – Alkermes

Alkermes announced that the FDA has approved Lybalvi (olanzapine and samidorphan) 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.

In the ENLIGHTEN clinical development program, Lybalvi demonstrated antipsychotic efficacy, safety and tolerability, including statistically significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study. Results from the ENLIGHTEN program’s pivotal ENLIGHTEN-1 efficacy study and ENLIGHTEN-2 weight study have been published in peer-reviewed journals and are included in the approved labeling for Lybalvi.

The FDA approved Lybalvi under the 505(b)(2) regulatory pathway based on data from 27 clinical studies, including 18 studies evaluating Lybalvi and nine studies evaluating samidorphan alone, and the FDA’s findings of safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia. Data suggest that olanzapine-associated weight gain is disease independent.