Macugen
Generic name: pegaptanib
Treatment for: Macular Degeneration
Eyetech/Pfizer File New Drug Application for Macugen (pegaptanib sodium injection), the First Investigational Anti-VEGF Therapy for Wet Age-Related Macular Degeneration
NEW YORK, June 17, 2004 -- Eyetech Pharmaceuticals, Inc. (NASDAQ:EYET) and Pfizer Inc (NYSE:PFE) today announced that they have completed the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Macugen (pegaptanib sodium injection) as a treatment for wet age-related macular degeneration, the leading cause of severe vision loss in patients older than 50 years of age in the developed world. Macugen received fast track designation from the FDA, which is a process intended for products that address unmet medical needs. The NDA was also entered into the "Pilot 1" program, which allows the FDA to complete reviews of individual reviewable units within six months of submission and provide early feedback on the pre-submissions. In addition, the FDA recently announced that 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 wet AMD.
About Eyetech Pharmaceuticals, Inc.
Eyetech Pharmaceuticals, Inc. is a biopharmaceutical company that specializes in the development and commercialization of novel therapeutics to treat diseases of the eye. Eyetech's initial focus is on diseases affecting the back of the eye. The company's most advanced product candidate is Macugen, which Eyetech is developing with Pfizer Inc for the prevention and treatment of diseases of the eye and related conditions. Eyetech's lead clinical trials include two phase 2/3 pivotal clinical trials for the use of Macugen in the treatment of the wet form of age-related macular degeneration, a phase 2 clinical trial for the use of Macugen for the treatment of diabetic macular edema and a phase 2 clinical trial for the use of Macugen in the treatment of retinal vein occlusion.
About Pfizer Ophthalmics
Pfizer Ophthalmics, a division of Pfizer Inc, is dedicated to preserving sight and preventing blindness in patients with ocular diseases.
Source: Eyetech Pharmaceuticals, Inc.; Pfizer Inc
Posted: June 2004
Related articles
- Macugen Eyetech / Pfizer Inc - Treatment for Neovascular (Wet) Age-Related Macular Degeneration - December 17, 2004
- FDA Advisory Committee Reviews Clinical Data of Eyetech/Pfizer Priority 1 NDA Submission for Macugen, an Investigational Treatment for Neovascular AMD - August 27, 2004
- Eyetech/Pfizer Announce FDA Acceptance of the New Drug Application for Macugen (pegaptanib sodium injection) - August 18, 2004
- FDA Announces Advisory Committee Meeting Date for Macugen (pegaptanib sodium injection) - May 26, 2004
Macugen (pegaptanib) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
