Pegaptanib approval process begins overseas

San Carlos, CA-The international approval process of pegaptanib sodium injection (Macugen) as a potential treatment for neovascular age-related macular degeneration is under way, as the companies begin filings in Europe, Canada, and Japan.

Nektar Therapeutics, Pfizer Ophthalmics, and Eyetech Pharmaceuticals Inc. said the European Medicines Agency has accepted the filing of their marketing authorization application. The companies also have filed a new drug application in Canada, where it has been designated for priority review. Meanwhile, clinical trials have begun in Japan.

The drug is under priority review by the FDA. It is being developed by Eyetech Pharmaceuticals with PEGylation technology from Nektar Therapeutics. Pfizer Ophthalmics holds marketing rights to the drug outside the United States, and will pay royalties to Eyetech Pharmaceuticals for those sales. Pfizer Ophthalmics and Eyetech Pharmaceuticals will share marketing responsibilities within the United States.