Macugen
pegaptanib
Treatment for Macular DegenerationFDA 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.
For further information about Eyetech Pharmaceuticals, Inc., please
visit www.eyetk.com
About Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leading
prescription medicines for humans and animals in many of the
world's best-known consumer brands.
For more information about Pfizer, please visit www.pfizer.com.
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
FDA Announces Advisory Committee Meeting Date for Macugen (pegaptanib sodium injection) - May 26, 2004
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