Concomitant Use Of Macugen With Visudyne Appears Safe, Cmte. Says
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
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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. "I think it's been explored sufficiently, and I don't have concerns about concomitant use," voting consultant Scott Steidl, MD (Baltimore) said during the advisory committee's review of Macugen for the treatment of neovascular (or "wet") age-related macular degeneration. Photodynamic therapy (PDT) with verteporfin is currently the only approved treatment for AMD, with an indication limited to patients with the predominantly classic form of the disease. In Macugen clinical trials, doctors were permitted to administer PDT to patients; however, patients were not randomized to PDT (1 (Also see "Macugen Advisory Committee To Discuss Concomitant Use With Visudyne" - Pink Sheet, 25 Aug, 2004.)). Only 25% of patients received PDT at any time, according to the 2 sponsors' briefing documents. The committee voted 9-0 that the concomitant use of Macugen with Visudyne had been sufficiently explored, even though the number of patients who received both therapies was too small to allow any conclusions about the influence of Visudyne. "I would just have to caution...that there are small numbers, but the data they do have don't raise a concern for me," voting committee consultant Jeffrey Lehmer, MD, (Bakersfield, Calif.) said. "The number of patients who received photodynamic therapy…were so small that we really can't make any conclusions about whether receiving photodynamic therapy before or during the trial has any effect on the efficacy results," FDA Division of Anti-Inflammatory, Analgesic & Ophthalmic Drug Products Medical Officer Jennifer Harris, MD, said. Committee members and the sponsors agreed that future studies should explore possible effects from concomitant use. "I think we would all like to know ultimately if there's a synergistic effect," Steidl said. "One of the things that was important to us when we designed this trial was to try to make it as much of a real world trial as possible, and that's why we allowed photodynamic therapy," Eyetech CEO David Guyer, MD, said. "I agree with you that certainly future trials will be able to address those issues and it's important," he added. - John Rancourt, Andrew Shelton |