Pfizer, Inc (NYSE: PFE), New York, has notified the European Medicines Agency (EMA) of its decision to withdraw an application to extend the therapeutic indication for its anti-VEGF pegaptanib sodium drug (Macugen). The company had submitted an application to extend Macugen’s marketing authorisation to include the treatment of visual impairment due to diabetic macular edema (DME) in June 2010. The decision was made following the receipt of an official letter from the EMA stating that in the view of the Committee for Medicinal Products for Human Use (CHMP) the drug did not have a positive risk-benefit profile for the particular indication sought.
Pfizer withdraws application for an extension of the indication for Macugen
- by swdadmin