Vanda Pharma's Fanapt approved for bipolar disorder in USA

First approved in 2009 as a treatment for schizophrenia, Vanda Pharmaceuticals’ (Nasdaq: VNDA) Fanapt (iloperidone) has now won US regulatory approval for a new indication, with the news sending the US drugmaker’s shares up 33% to $5.23.

The US Food and Drug Administration (FDA) has authorized Fanapt for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. The marketing approval of Fanapt in bipolar I disorder with manic and mixed episodes significantly increases the commercial opportunity for the drug.

"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 Dr Mihael Polymeropoulos Vanda's president, chief executive and chairman of the board.