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The FDA approved Lybalvi in June 2021 to treat schizophrenia and bipolar disorder.
Alkermes has launched 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. It was approved in June 2021 based on the ENLIGHTEN clinical program. In the ENLIGHTEN-1 study of 403 patients experiencing an acute exacerbation of schizophrenia, Lybalvi demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) scores compared with placebo.
In the ENLIGHTEN-2 study of 561 patients with stable schizophrenia, Lybalvi met the two primary endpoints, demonstrating both a lower mean percent weight gain from baseline at six months compared with the olanzapine group and a lower proportion of patients who gained 10% or more of their baseline body weight at six months compared with the olanzapine group.
“Patients living with bipolar I disorder or schizophrenia commonly cycle through multiple therapeutic options in the course of their treatment journey. The availability of a new, efficacious and differentiated treatment option is a significant development for patients as they make treatment decisions with their healthcare provider,” Michael Pollock, CEO of the Depression and Bipolar Support Alliance, said in a statement.