Alkermes secures FDA approval of Lybalvi for schizophrenia and bipolar I disorder

Alkermes has secured US FDA approval for 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.

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

“Lybalvi represents an important new treatment option for adults with schizophrenia or bipolar I disorder, their clinicians and caregivers, and reflects Alkermes’ commitment to developing new therapies that support patient-centered care,” said Richard Pops, Chairman and CEO at Alkermes.

“We share this accomplishment with our employees and the many researchers, advocates, clinicians and patients who have been essential to the Lybalvi development programme since its inception.

“Our existing commercial capabilities and presence in the antipsychotic market with Aristada provide an important foundation for the commercialization of Lybalvi, and we look forward to making this new medicine available to patients and clinicians later this year.”

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.

Alkermes expects to make Lybalvi available for patients in the fourth quarter of 2021.

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