Alkermes receives FDA nod for Lybalvi

The Food and Drug Administration has cleared Alkermes' 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.

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

"Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety. Olanzapine, a highly-efficacious atypical antipsychotic, is associated with significant side effects, including weight gain, that may impact patients' treatment experiences and limit its use," said René Kahn, Esther and Joseph Klingenstein professor & chair, department of Psychiatry and Behavioral Health System at the Icahn School of Medicine at Mount Sinai. "With the efficacy of olanzapine and evidence of less weight gain in patients with schizophrenia, Lybalvi brings a welcome new addition to our medication arsenal."

"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, Alkermes chairman and CEO. "We share this accomplishment with our employees and the many researchers, advocates, clinicians and patients who have been essential to the Lybalvi development program 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."

Alkermes expects Lybalvi to be available in the fourth quarter of 2021.