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FDA approves Alkermes’ Lybalvi for schizophrenia and bipolar I disorder

Alkermes’ oral atypical antipsychotic drug Lybalvi has received approval from the US Food and Drug Administration for the treatment of schizophrenia and bipolar I disorder.
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.
In the ENLIGHTEN-1 study, which evaluated the antipsychotic efficacy, safety and tolerability of Lybalvi compared to placebo, the drug demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) scores compared to placebo.
“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-centred care,” said Richard Pops, chairman and chief executive officer 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 program since its inception. Our existing commercial capabilities and presence in the antipsychotic market with Aristada provide an important foundation for the commercialisation of Lybalvi, and we look forward to making this new medicine available to patients and clinicians later this year,” he added.
In a statement, Alkermes said that it is expecting to make Lybalvi available for patients in the fourth quarter of 2021.