Vanda Pharma pulls EU application for schizophrenia drug candidate Fanaptum

15 March 2013

The European Medicines Agency has been formally notified by USA-based Vanda Pharmaceuticals (Nasdaq: VNDA) that it is withdrawing its application for a centralized marketing authorization for Fanaptum (iloperidone), a drug intended to be used for the treatment of schizophrenia.

The application for Fanaptum was submitted to the Agency June 27, 2011. On December 13, 2012, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of a marketing authorization for the product. The company has requested a re-examination of the opinion (The Pharma Letter December 17, 2012). At the time of the withdrawal, the drug was under review by the CHMP.

In its official letter, the company stated that it is withdrawing the application because the CHMP identified missing data which will not be available in a timeframe acceptable in the centralized procedure.

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