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FDA Accepts New Drug Application for Pegaptanib Sodium Injection
NEW YORK, Aug. 17 /PRNewswire-FirstCall/ -- Eyetech Pharmaceuticals, Inc. and Pfizer Inc today announced that their complete New Drug Application (NDA) for Macugen™ (pegaptanib sodium injection) has been accepted by the U.S. Food and Drug Administration (FDA). The acceptance of the NDA satisfied a milestone provision in our collaboration agreement for a further license fee payment from Pfizer to Eyetech of $10 million. Eyetech and Pfizer are partnering to develop and market Macugen, a treatment for neovascular age-related macular degeneration, the leading cause of severe vision loss in patients older than 50 years of age in the developed world.
As part of the Macugen NDA filing, Eyetech and Pfizer requested and have now been granted Priority Review designation from the FDA. Based on the Priority Review designation, the FDA has six months from the submission date, to take action on the NDA filing. The companies submitted the final portion of the NDA, the chemistry, manufacturing and controls (CMC) component, on June 17, under the FDA's Fast Track designation. The FDA and its Dermatologic and Ophthalmic Drugs Advisory Committee will review Macugen on August 27, 2004.
Macugen is a pegylated anti-VEGF aptamer, which binds to and thus inhibits the activity of vascular endothelial growth factor (VEGF). VEGF is a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two of the primary pathological processes responsible for the vision loss associated with neovascular AMD.
Source: Eyetech Pharmaceuticals, Inc.; Pfizer Inc.