Vanda Pharmaceuticals received approval from the Food and Drug Administration for its treatment of a type of bipolar disorder as well as schizophrenia.
The biopharmaceutical company said Friday 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.
Vanda expects Bysanti will be commercially available in the third quarter of this year. 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.
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 company said.
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.
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