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Vanda withdraws EU application for schizophrenia drug

CHMP had previously refused to back the approval of Fanaptum

Vanda Pharmaceuticals has decided to withdraw its EU marketing application for the use of Fanaptum to treat schizophrenia.

The US biopharma had originally applied to the European Medicines Agency (EMA) in June 2011, but Fanaptum (oral iloperidone) was turned down for approval by the Committee for Medicinal Products for Human Use (CHMP) in December 2012 following a lengthy appraisal period.

At the time, the CHMP said that trials demonstrated the short-term effectiveness of Fanpatum was only “modest” when compared to placebo, while data for long-term effectiveness was not sufficient.

The drug was also said to have a delayed onset of action – a disadvantage, according to the CHMP.

To add to these concerns with Fanaptum's efficacy, the CHMP also noted potential safety worries to do with the drug, which has been shown to increase the 'QT interval' of a person's heartbeat – an effect that can lead to arrhythmias.

“The Committee considered that this risk was significant and not manageable by the risk-minimisation measures proposed by the company,” said the EMA.

Vanda requested a re-examination of the data last month, but has now decided to withdraw its application completely.

In its letter of withdrawal, Vanda stated that the CHMP requested data from the ongoing REPRIEVE trial involving Fanaptum's use in people with schizophrenia that would not be available in the timeframe allowed.

The EMA said more information about the drug and its withdrawal will be made available after the next CHMP meeting held March 18-21.

Vanda said that once the results of the REPRIEVE study are available, it will "reassess its European regulatory strategy for Fanaptum”.

Despite the struggle for approval in the EU, the drug has been available for people with schizophrenia in the US since 2009, where it is sold under the brand name Fanapt.

15th March 2013

From: Sales, Regulatory



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