Vanda Pharmaceuticals Receives FDA Approval for BYSANTI to Treat Bipolar I and Schizophrenia

Vanda Pharmaceuticals (NASDAQ: VNDA) announced that it has received FDA-approval for its new drug known as BYSANTI. The drug is meant to treat Bipolar I manic episodes as well as Schizophrenia symptoms in adults. BYSANTI tablets were approved for the acute treatment of manic or mixed episodes associated with bipolar I disorder, as well as for the treatment of schizophrenia in adults.

The approval marks Vanda's second FDA win in less than two months, following the December approval of NEREUS™. Vanda stock surged 44% after-hours as investors piled into the stock after the announcement.

This is a major breakthrough for Vanda, given that the new drug has been categorised as a "New Chemical Entity", a designation that usually comes with robust patient protection. The company's patent of the new drug extends up to 2044. Therefore, it does not have to deal with generic competitors for almost two decades. 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.

BYSANTI™, also known as "milsaperidone" was approved much faster than most new drugs because it is closely related to an older drug called Fanapt. While BYSANTI is a new entity, it demonstrates bioequivalence to iloperidone (marketed as Fanapt®). This allows Vanda to enter the market with a "trusted safety profile" backed by over 100,000 patient-years of real-world data. The drug works by modulating dopamine and serotonin pathways, but its unique "strong alpha-adrenergic binding" could make it a preferred choice for patients suffering from acute agitation and hostility.

Vanda expects Bysanti will be commercially available in the third quarter of this year. The drug is currently being tested as a treatment for major depressive disorder, with the results expected by the end of 2026, which could significantly expand its market size and future revenues. BYSANTI is also 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.

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.