Fanapt iloperidone regulatory update

Vanda disclosed in its 2Q12 earnings that it requested an extension to submit responses to Day 180 questions from EMA's CHMP related to the review of an MAA for iloperidone to treat schizophrenia. The company, which received the questions in July, hopes to be granted an extension to reply by mid-October and participate in an oral hearing in November.

Separately, Vanda said Israel approved the product as Fanapt to treat schizophrenia. Vanda will supply the product to MegaPharm Ltd. (Raanana, Israel), which has exclusive commercialization rights in Israel from Vanda under a 2011 deal (see BioCentury, Dec. 19, 2011). ...