FDA expands prescribing information for Fanapt (iloperidone) for schizophrenia in adults- Vanda Pharma
The FDA has approved Vanda Pharma's supplemental New Drug Application (sNDA) for Fanapt (iloperidone) modifying and expanding the prescribing information (PI) to describe the effectiveness of Fanapt as a maintenance treatment for schizophrenia in adults.
FDA approval was based on the results of the REPRIEVE (Relapse prevention study in patients with schizophrenia) placebo-controlled clinical study which evaluated the long-term maintenance of efficacy and safety of Fanapt. The study data submitted in the sNDA came from the REPRIEVE study in which Vanda previously reported 79.6% of patients treated with Fanapt remained relapse free compared to 36.6% for placebo-treated patients.
Comment:The FDA is also currently reviewing Vanda's application for three years marketing exclusivity based upon the REPRIEVE study submission and subsequent PI changes and expansion now approved in the sNDA.
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