FDA Approves a New Atypical Antipsychotic With Less Adverse Effects

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The US Food and Drug Administration announced their approval of Alkermes’ LYBALVI, a combination of olanzapine and samidorphan, for the treatment of adults with schizophrenia and/or bipolar I disorder. LYBALVI is a once-daily, atypical antipsychotic that works as a maintenance monotherapy for the acute treatment of manic or mixed episodes, or as an adjunct to lithium or valproate.

“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,” Richard Pops, Chairman and Chief Executive Officer at Alkermes, said to the press. “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.”¹

In the ENLIGHTEN clinical development program, the novel antipsychotic demonstrated efficacy, safety, and tolerability. Most notably, patients taking LYBALVI experienced statistically significant less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study. The ENLIGHTEN program’s results, including the pivotal ENLIGHTEN-1 efficacy study and the ENLIGHTEN-2 weight study, are published in peer-reviewed journals.^2,3

“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 S. Kahn, MD, PhD, 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.”¹

This approval comes under the 505(b)(2) regulatory pathway and is based upon data from 27 clinical studies, including 18 studies evaluating LYBALVI and 9 studies evaluating samidorphan alone, as well as the FDA’s findings of safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia. According to the data, olanzapine-associated weight gain may be disease independent.⁴

“People living with schizophrenia or bipolar I disorder must evaluate both efficacy and tolerability when making treatment decisions,” said Paul Gionfriddo, President and CEO of Mental Health America. “We are grateful that companies like Alkermes are driven to continue developing new treatment options in psychiatry that seek to address unmet needs of our community and we applaud the FDA for considering the experiences of individuals living with these conditions.”¹ 

Alkermes hopes to make LYBALVI available for patients in the fourth quarter of 2021.

References

1. Alkermes. Alkermes announces FDA approval of LYBALVI™ for the treatment of schizophrenia and bipolar I disorder. News release. June 1, 2021. https://investor.alkermes.com/news-releases/news-release-details/alkermes-announces-fda-approval-lybalvitm-treatment

2. Potkin SG, Kunovac J, Silverman BL, et al. Efficacy and safety of a combination of olanzapine and samidorphan in adult patients with an acute exacerbation of schizophrenia: outcomes from the randomized, phase 3 ENLIGHTEN-1 study. J Clin Psych. 2020;81(2):19m12769. 

3. Correll CU, Newcomer JW, Silverman BL, et al. Effects of olanzapine combined with samidorphan on weight gain in schizophrenia: A 24-week phase 3 study. Am J Psychiatry. 2020;(177)12:1168-1178.

4. Zyprexa US Prescribing Information. Eli Lilly and Company. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020592s074,021086s048,021253s061lbl.pdf