NDA for neovascular AMD drug
The FDA has accepted Eyetech Pharmaceuticals' and Pfizer's complete New Drug Application (NDA) for Macugen (pegaptanib sodium injection).
The FDA has accepted Eyetech Pharmaceuticals' and Pfizer's complete New Drug Application (NDA) for Macugen (pegaptanib sodium injection).
The acceptance of the NDA satisfied a milestone provision in their collaboration agreement for a further license fee payment from Pfizer to Eyetech of $10m. 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 under the FDA's fast track designation. 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.