Vanda Withdraws Its Marketing Authorization Application For Fanaptum In The European Union

Vanda Pharmaceuticals

announced today that it has withdrawn its Marketing Authorization Application (MAA) submitted to the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Fanaptum™ (oral iloperidone tablets) for the treatment of adult patients with schizophrenia. This withdrawal is based on a request by the CHMP/Rapporteur/Co-rapporteur for Vanda to submit the results from an ongoing relapse prevention, randomized iloperidone-placebo withdrawal study in patients with schizophrenia. The results of this study will not be available in the timeframe allowed in the Centralised Procedure. Vanda intends to reassess its European regulatory strategy for Fanaptum™ once the results from the Relapse Prevention Study in Patients with Schizophrenia (REPRIEVE) become available. About Vanda Pharmaceuticals Inc.: Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders. For more on Vanda, please visit www.vandapharma.com.