BioCentury
ARTICLE | Clinical News

Fanapt iloperidone regulatory update

December 17, 2012 8:00 AM UTC

EMA's CHMP issued a negative opinion against approval of Vanda's 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. ...