Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has issued a positive opinion on Progenics Pharmaceuticals' Relistor (methylnaltrexone bromide) subcutaneous injection in pre-filled syringes.
Progenics is also seeking approval to market Relistor in pre-filled syringes in the US and awaits FDA action.
Progenics expects that pre-filled syringe commercial launches would occur in the US and EU in the second quarter of 2011.
Relistor subcutaneous injection is approved in the US for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
Relistor drug is also approved for use in over 50 countries worldwide, including the EU, Canada, Australia and Brazil. Applications in additional countries are pending.