Vanda Pharmaceuticals withdraws EU MMA for Fanaptum to treat Schizophrenia
Vanda Pharmaceuticals has withdrawn its Marketing Authorization Application (MAA) submitted to the EMA's Committee for Medicinal Products for Human Use (CHMP) for Fanaptum (oral iloperidone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. 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.
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