Fanaptum iloperidone regulatory update

Vanda disclosed in its 2012 earnings that it requested re-examination of a December negative opinion from EMA's CHMP for Fanaptum iloperidone to treat schizophrenia. CHMP said the short-term efficacy of the compound was "modest" compared to placebo and that the long-term efficacy has not been "sufficiently shown." The committee also said the compound was associated with a "significant" risk of QT prolongation that was not manageable by the company's proposed risk minimization measures (see BioCentury, Dec. 17, 2012). ...