Vanda Pharmaceuticals has been stunned by a recommendation from European regulators that the US firm's schizophrenia drug Fanaptum should not get the green light.
The European Medicines Agency's Committee for Medicinal Product for Human Use has issued a negative opinion recommending against approval of Fanaptum (iloperidone) foral tablets for the treatment of schizophrenia in adults in the European Union. The CHMP believes that the benefits of Fanaptum did not outweigh its risks and recommended against marketing authorisation at this point in time.
Vanda intends to appeal this opinion and request a re-examination of the decision by the CHMP. The company had prepared for an oral hearing on Fanaptum in November after having submitted more data earlier this year to the EMA.
The drug has been marketed in North America by Novartis since 2010, as Fanapt, but in October this year, the Swiss major noted that it is discontinuing development on a long-acting injectable version.