The approval was supported by two placebo-controlled Phase III clinical studies comparing Fanapt to placebo and active control in patients with schizophrenia, as well as safety data from more than 3,000 patients.
Both trials enrolled patients who met the DSM-III/IV criteria for schizophrenia, and Fanapt was shown to be superior to placebo in controlling symptoms of schizophrenia across doses of 12mg to 24mg per day. The recommended target dose range of Fanapt is 12mg to 24mg per day. Titration to the target dose of 12mg per day can be achieved in four days, said Vanda.
Mihael Polymeropoulos, Vanda’s CEO, said: “The approval of Fanapt by the FDA represents many years of tireless efforts by current and former colleagues, many investigators and thousands of patients who participated in the development of this new treatment for schizophrenia.
“I would like to extend my gratitude to all those who contributed and reaffirm the commitment of Vanda Pharmaceuticals to the discovery and development of medicines for those in need.”