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Pfizer withdraws application
Pfizer has withdrawn its application to the European Medicines Agency for an extension of the therapeutic indication for 0.3-mg pegaptanib sodium (Macugen) injection to include treatment of visual impairment due to diabetic macular edema (DME).
London-Pfizer has withdrawn its application to the European Medicines Agency for an extension of the therapeutic indication for 0.3-mg pegaptanib sodium (Macugen) injection to include treatment of visual impairment due to diabetic macular edema (DME).
The company had submitted the application in June 2010, and the agency’s Committee for Medicinal Products for Human Use (CHMP) was reviewing it. Pfizer said that it withdrew its application because the CHMP believed it could not reach a conclusion on a positive benefit-risk balance for DME based on the data provided. The withdrawal of an application does not preclude the possibility of the company filing a new application later.
In the European Union, pegaptanib is approved for the treatment of neovascular age-related macular degeneration.
