Vanda's Fanapt receives FDA approval for bipolar I disorder indication

Vanda Pharmaceuticals Inc.

FDA approved Fanapt (iloperidone) on April 2, 2024 for acute treatment of manic or mixed episodes in bipolar I disorder in adults.
Approval based on pivotal study of ~400 patients; primary endpoint YMRS at Week 4 highly statistically significant (p=0.000008).
Fanapt was previously approved for schizophrenia in 2009; safety profile consistent across indications.
Vanda CEO cites significant increase in commercial opportunity; bipolar I disorder affects ~10M Americans.

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