Vanda’s Fanapt Secures Second FDA Approval for Treating Bipolar I Disorder

1. Vanda Pharmaceuticals achieved a second FDA approval for their drug Fanapt (iloperidone) to treat adults experiencing manic or mixed episodes related to Bipolar I disorder.
2. This approval follows Fanapt's initial FDA approval in 2009 for treating schizophrenia, marking a milestone 15 years apart between the two approvals.
3. The FDA's decision was supported by a phase 3 trial involving 400 patients, where Fanapt demonstrated significant improvements on the Young Mania Rating Scale within four weeks compared to placebo.
4. Despite earlier revenue successes, Vanda has recently seen a decrease in sales due to generic competition affecting one of their other products, Hetlioz (tasimelteon).
5. With this new indication, Vanda hopes to increase the commercial potential of Fanapt, especially considering there are approximately 10 million people in the US living with Bipolar I disorder.
6. Fanapt carries a black box warning regarding an increased risk of death among elderly patients with dementia-related psychosis when treated with antipsychotics like Fanapt.
7. Vanda is also pursuing additional indications for Fanapt, including post-traumatic stress disorder (PTSD).
8. The company's share price increased by approximately 40% following the announcement of this new approval.