Axcan Pharma Inc announced that the Gastrointestinal Advisory Committee of the U.S. Food and Drug Administration has agreed that Axcan's investigational drug, Photofrin PDT, demonstrated efficacy and safety in the ablation of High-Grade Dysplasia associated with Barrett's Esophagus. The announcement was made following a review by the Committee of clinical data on Photofrin (porfirmer sodium) with Photodynamic Therapy (PDT) in this indication. Axcan received an approvable letter from the FDA in the first quarter of fiscal 2003 and Photofrin PDT was recently approved in Canada for the same indication.
"We are very pleased that the Advisory Committee overwhelmingly agreed with the efficacy and safety of Photofrin PDT in this indication," commented Francois Martin, Senior Vice President, Scientific Affairs of Axcan. "Although the Committee was not asked to vote on whether it recommended Photofrin for approval, we now expect that the FDA will give us a final response by the end of Axcan's fiscal year," he concluded.
The Advisory Committee reviewed efficacy and safety data from studies with Photofrin PDT. Axcan submitted the results of three clinical trials in which Photofrin PDT was used for mucosal ablation of High-Grade Dysplasia. Photofrin is an approved photosensitizing agent that is administered intravenously and is innocuous until activated by light. When target tissues are exposed to laser light at 630 nm, tissue necrosis occurs by at least two mechanisms, oxygen radical damage and anoxia due to thrombosis of capillaries.