FDA approval for Fanapt (iloperidone) tablets to treat manic or mixed episodes associated with bipolar I disorder in adults – Vanda Pharma

Vanda Pharmaceuticals Inc announced that the FDA has approved Fanapt (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Fanapt is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009.

“Manic or mixed episodes associated with bipolar I disorder are highly complex conditions, which require a host of trusted options to meet individual patient needs. With over 100,000 patient years of experience, Fanapt is a familiar therapeutic agent that offers flexible dosing with a well-known safety profile. This FDA approval gives patients and service providers a new treatment option for managing bipolar I disorder,” said Mihael H. Polymeropoulos M.D., Vanda’s President, CEO and Chairman of the Board.

Bipolar disorder is a serious, highly prevalent psychiatric chronic condition affecting approximately 2.8% of the U.S. adult population, with 83% of them classified as severe. Bipolar disorder is a group of disorders that are characterized by periods of elevated mood alternating with periods of depressed mood. For the diagnosis of bipolar I disorder, people must have experienced one or more episodes of mania and most would have episodes of both mania and depression. Patients with bipolar I disorder with manic or mixed episodes are a subset of those approximately 10 million Americans with bipolar disorder.

The marketing approval of Fanapt in bipolar I disorder with manic and mixed episodes significantly increases the commercial opportunity for Fanapt .

Stephen Stahl , MD, PhD, Professor of Psychiatry at the University of California San Diego, said, “Many patients today are still unable to find suitable treatment options for effectively managing bipolar disorder. Tailoring the right treatment for the right patient is critical for effective care, and the approval of Fanapt represents an important milestone. Fanapt possesses a well-studied safety profile, and its approval will provide patients with a new and effective option for treating a highly complex disorder.”