Macugen
Generic name: pegaptanib
Treatment for: Macular Degeneration
FDA Advisory Committee Reviews Clinical Data of Eyetech/Pfizer Priority 1 NDA Submission for Macugen, an Investigational Treatment for Neovascular AMD
NEW YORK, August 27, 2004 -- Eyetech Pharmaceuticals, Inc. (NASDAQ:EYET) and Pfizer Inc (NYSE:PFE) announced that the U.S. Food and Drug Administration's (FDA) Dermatologic & Ophthalmic Drugs Advisory Committee met today to review the clinical submission for the investigational drug Macugen (pegaptanib sodium injection) for the treatment of neovascular age-related macular degeneration (AMD).
Macugen is currently under priority review status by the FDA, a designation given to products that address an unmet medical need.
In accordance with the rolling submission process of a priority review, a formal vote was not taken today by the advisory committee.
The FDA takes into consideration the deliberations of the advisory committee as part of its review of New Drug Applications (NDAs). Eyetech and Pfizer submitted the NDA for Macugen on June 17.
The companies are pleased to have the opportunity to meet with the FDA and its advisory committee and look forward to further dialogue with the agency so Macugen may be made available to the many people who may go blind due to neovascular 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 (pegaptanib sodium injection), 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 neovascular 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.
Posted: August 2004
Related articles
- Macugen Eyetech / Pfizer Inc - Treatment for Neovascular (Wet) Age-Related Macular Degeneration - December 17, 2004
- Eyetech/Pfizer Announce FDA Acceptance of the New Drug Application for Macugen (pegaptanib sodium injection) - August 18, 2004
- Eyetech/Pfizer File New Drug Application for Macugen (pegaptanib sodium injection), the First Investigational Anti-VEGF Therapy for Wet Age-Related Macular Degeneration - June 17, 2004
- FDA Announces Advisory Committee Meeting Date for Macugen (pegaptanib sodium injection) - May 26, 2004
Macugen (pegaptanib) FDA Approval History
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