FDA Approves Vanda's Bysanti for Schizophrenia and Bipolar I Disorder

The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals' drug for the treatment of two serious mental health conditions, the company said on Friday, sending its shares surging 30% in extended trading. The drug, branded as Bysanti, is an antipsychotic pill aimed at treating schizophrenia and acute bipolar I disorder.

Bysanti, chemically known as milsaperidone, belongs to a class of drugs known as atypical antipsychotics that work by blocking dopamine and serotonin receptors in the brain, which help regulate mood, stress, delusions and alertness.

Vanda said it expects to launch the drug in the U.S. in the third quarter. The company expects that marketing exclusivity for the drug will be protected by regulatory data exclusivity and issued U.S. patents, with the latest expiring in 2044.

Schizophrenia is a serious mental illness that can cause hallucinations and delusions, while bipolar disorder is marked by dramatic shifts in mood and energy that can disrupt sleep, judgment and daily functioning. Bipolar I disorder affects a significant portion of the roughly 10 million Americans with bipolar disorder, and is characterized by manic or mixed episodes. Schizophrenia affects about 1% of the adult population, or about 2.8 million people, and can cause functional impairment, frequent hospitalizations and diminished quality of life.

The approval adds another psychiatric drug to Vanda's portfolio. Fanapt, chemically known as iloperidone, is already approved in the U.S. for the same conditions. Vanda has said that studies indicate milsaperidone changes into iloperidone soon after being absorbed in the body, and that patients end up with similar drug levels whether they take milsaperidone or iloperidone. Its safety profile is similar to that of iloperidone, Vanda said.

Bristol Myers Squibb's Cobenfy for schizophrenia and Johnson & Johnson's Caplyta for schizophrenia and bipolar I or II depression are among other approved antipsychotics.

Vanda is also studying the drug as a once-daily add-on treatment for major depressive disorder, with results expected later this year. Bysanti is currently being tested as a once-daily adjunctive treatment in treatment-resistant major depressive disorder in an ongoing clinical study expected to be completed by the end of this year.