US FDA approves Vanda's antipsychotic pill for schizophrenia and bipolar I disorder

The U.S. Food and Drug Administration approved Vanda Pharmaceuticals' antipsychotic pill Bysanti (milsaperidone) for schizophrenia and acute bipolar I disorder, and Vanda said it expects a U.S. launch in the third quarter.

The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals' antipsychotic pill Bysanti for the treatment of schizophrenia and acute bipolar I disorder. Bysanti is chemically known as milsaperidone and belongs to the atypical antipsychotic class. Vanda said it expects to launch the drug in the United States in the third quarter. Reuters reported that the company's shares rose sharply in extended trading after the announcement. Key facts: - The FDA approval covers Bysanti (milsaperidone) for schizophrenia and acute bipolar I disorder, as reported on Feb. 20. - Bysanti is described as an atypical antipsychotic that works by blocking dopamine and serotonin receptors in the brain. - Vanda said it expects a U.S. launch in the third quarter, and the article reported a roughly 30% rise in the company's shares in extended trading after the approval. - Vanda already markets Fanapt (iloperidone) for the same conditions; the company said studies indicate milsaperidone converts into iloperidone after absorption and produces similar drug levels and a similar safety profile. - Other antipsychotics named in the report include Bristol Myers Squibb's Cobenfy and Johnson & Johnson's Caplyta for related psychiatric uses. - Vanda is also studying Bysanti as a once-daily add-on treatment for major depressive disorder, with results expected later this year; the article cited Jefferies analyst Andrew Tsai, who modeled potential sales and questioned uptake if Fanapt goes generic in 2027–2028. Summary: The approval adds another branded antipsychotic option and was followed by a notable market reaction for Vanda, according to the report. Vanda plans a U.S. launch in the third quarter and is awaiting study results of Bysanti as an add-on for major depressive disorder later this year. How the drug will be used in clinical practice and in the market is undetermined at this time.