Vanda Pharmaceuticals Receives FDA Approval for Schizophrenia Drug
On-site corporate partner Vanda Pharmaceuticals recently announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval of Fanapt™ (iloperidone) for the treatment of adult patients with schizophrenia.
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.
"Fanapt™ is an important option for psychiatrists in treating patients with schizophrenia. It is an effective antipsychotic with excellent tolerability," said Dr. Steven G. Potkin, Professor of Psychiatry and Human Behavior at the University of California at Irvine. "We also look forward to Vanda's continuing development of long-acting formulations of Fanapt™, to further address the significant unmet medical issues in this population of patients."
"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,” said Mihael H. Polymeropoulos, MD, Vanda's Chief Executive Officer. “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.”
Vanda plans to make Fanapt™ available in pharmacies later this year.