Macugen Advisory Committee To Discuss Concomitant Use With Visudyne
This article was originally published in The Pink Sheet Daily
Executive Summary
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
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Concomitant Use Of Macugen With Visudyne Appears Safe, Cmte. Says
Concomitant use of Pfizer/Eyetech's Macugen (pegatanib) with Novartis/QLT's Visudyne (verteporfin) does not pose safety concerns, FDA's Dermatologic & Ophthalmic Drugs Advisory Committee concluded Aug. 27.
Concomitant Use Of Macugen With Visudyne Appears Safe, Cmte. Says
Concomitant use of Pfizer/Eyetech's Macugen (pegatanib) with Novartis/QLT's Visudyne (verteporfin) does not pose safety concerns, FDA's Dermatologic & Ophthalmic Drugs Advisory Committee concluded Aug. 27.
Pfizer/Eyetech's Macugen Safety To Be Discussed By FDA Advisory Cmte.
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.