Tuesday, the FDA approved Vanda Pharmaceuticals Inc’s 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.

Bipolar disorder is a 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. 

Patients with bipolar I disorder with manic or mixed episodes are a subset of 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.

The approval of Fanapt for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder was based on a pivotal study randomizing approximately 400 patients. 

The primary endpoint measured in Week 4 of treatment was assessed by the Young Mania Rating Scale (YMRS), a rating scale of clinical severity in the core symptoms of mania. 

At the end of the study (Week 4), Fanapt-treated patients showed a larger improvement than placebo-treated patients, and this difference was highly statistically significant. 

A statistically significant benefit in the Fanapt-treated group over the placebo was observed as early as the Week 2 assessment. 

The safety profile of Fanapt in this study was similar to that seen in Fanapt studies previously conducted for the treatment of schizophrenia in adults.

Fanapt’s net product sales were $90.9 million for 2023, down 4% Y/Y.

Sales of Vanda’s sleep disorder drug, Hetlioz, have been falling due to increased competition from cheaper versions. Hetlioz declined 37.3% to $100.2 million.

Both drugs accounted for over 99% of the company’s revenue last year.

Price Action: VNDA shares are up 27.9% at $5 during the premarket session on the last check Wednesday.