Pfizer/Eyetech's Macugen Safety To Be Discussed By FDA Advisory Cmte.
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency will ask the committee to discuss the potential impact of VEGF inhibition on cardiovascular events. FDA also will seek input on whether Macugen's efficacy was adequately demonstrated; only one of three tested doses of the macular degeneration drug showed a statistically significant effect in both clinical trials.
You may also be interested in...
Pfizer/Eyetech's Macugen: Advisory Cmte. Wants Long-Term Follow Up
While the committee finds the existing data were sufficient for approval, members call for long-term follow up to address safety concerns and duration of therapy. The committee also recommends labeling address endophthalmitis.
Pfizer/Eyetech's Macugen: Advisory Cmte. Wants Long-Term Follow Up
While the committee finds the existing data were sufficient for approval, members call for long-term follow up to address safety concerns and duration of therapy. The committee also recommends labeling address endophthalmitis.
Macugen Advisory Committee To Discuss Concomitant Use With Visudyne
FDA's Dermatologic and Ophthalmic Drugs Advisory Committee will discuss concomitant use of Pfizer/Eyetech's Macugen and Novartis/QLT's Visudyne (verteporfin) at an Aug. 27 meeting