Progenics announces EMA CHMP positive opinion for RELISTOR in pre-filled syringes

Aug 7 2010

Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has issued a positive opinion for RELISTOR^® (methylnaltrexone bromide) subcutaneous injection in pre-filled syringes. The CHMP is responsible for reviewing medicinal product applications for safety, quality and efficacy. The CHMP's positive opinion for RELISTOR will now be forwarded to the European Commission for a final decision.

Progenics is also seeking approval to market RELISTOR in pre-filled syringes in the U.S. and awaits FDA action. Pending respective approvals in the E.U. and U.S., Progenics expects that pre-filled syringe commercial launches would occur in the United States and European Union in the second quarter of 2011.

Source Progenics Pharmaceuticals, Inc.,