Pfizer withdraws extension of therapeutic indication for DME
Pfizer has notified the European Medicines Agency (EMA) that it will withdraw it's application for an extension on the therapeutic indication for Macugen.
Pfizer has notified the European Medicines Agency (EMA) that it will withdraw it's application for an extension on the therapeutic indication for Macugen.
The pegaptanib sodium, 0.3 mg solution for injection is currently authorized as a neovascular, wet age-related macular degeneration (AMD) treatment.
Pfizer had recently submitted an application to extend the marketing authorization of Macugen.
The firm's reason for withdrawing the application is that the EMA's Committee for Medicinal Products for Human Use (CHMP) believes a positive benefit-risk balance cannot be conducted with the information provided so far.
