FDA Grants Vanda 3 Years Exclusivity for Fanapt sNDA

FDA has granted Vanda Pharmaceuticals three years marketing exclusivity due to a supplemental NDA approved last month for Fanapt (iloperidone) that modified and expanded its prescribing information for use as a maintenance treatment for schizophrenia in adults. The agency added the exclusivity notice to its Orange Book providing marketing protection until 5/26/2019.

The sNDA included data from the long-term maintenance REPRIEVE clinical study, which demonstrated the drug’s ability to prevent relapse or impending relapse in adult patients with schizophrenia as compared to placebo, according to the company. In the study, 79.6% of patients treated with Fanapt remained relapse-free compared to 36.6% for placebo-treated patients.

Fanapt was approved in 2009 for treating adults with schizophrenia. Vanda licensed iloperidone in 2004 from Novartis Pharma AG and has a manufacturing arrangement with Canada’s Patheon Inc.