Posted by herpills on March 15, 2013, at 14:13:21
from pharmatimes.com...
Vanda pulls EU filing for schizophrenia drug
World News | March 15, 2013
Kevin GroganThe European Medicines Agency says it has been notified by Vanda Pharmaceuticals of the USA that it wants to withdraw its application for the schizophrenia drug Fanaptum (iloperidone) intended to be used for the treatment of schizophrenia.
The move comes as little surprise given that the agency's Committee for Medicinal Product for Human Use issued a negative opinion recommending against approval of Fanaptum in December last year. Vanda had requested a re-examination of the opinion in February but has now pulled the application.
The reason given is that the CHMP "identified missing data which will not be available in a timeframe acceptable in the centralised procedure". More details will be published after the monthly CHMP meeting starting March 18.
The drug has been marketed in North America by Novartis since 2010, as Fanapt, but in October, the Swiss major noted that it is discontinuing development on a long-acting injectable version.
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