Pfizer/Eyetech Macugen Filing Planned For Q3 In All Three AMD Subgroups
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Eyetech plans to submit its VEGF inhibitor Macugen in the third quarter for use in the three subtypes of wet age-related macular degeneration, the company noted in a prospectus for an initial public offering.
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Pfizer/Eyetech Macugen advisory committee
FDA's Dermatologic & Ophthalmic Drugs Advisory Committee will review Pfizer/Eyetech's Macugen (pegaptanib) for wet age-related macular degeneration Aug. 27. [Editor's Note: To 1watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.] Completion of the rolling submission, under FDA's fast track provisions, is slated for the third quarter. Priority review was requested, Eyetech says. Pivotal data includes all three AMD subtypes; approval in each would give Macugen an edge over Novartis/QLT's Visudyne (verteporfin), indicated for predominantly classic subfoveal AMD (2Pharmaceutical Approvals Monthly Feb. 1, 2004, p. 6)...