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Axcan files Photofrin sNDA for Barrett’s esophagus

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Axcan supplemental NDA for Photofrin (porfimer photodynamic therapy) for treatment of high-grade dysplasia associated with Barrett's esophagus is granted orphan drug status. The filing is based on a 208-patient Phase III study showing ablation of dysplasia in 72% of patients using Photofrin plus oral omeprazole (AstraZeneca's Prilosec) vs. 31% for omeprazole alone (p<0.0001). A trend toward reduction of progression to esophageal cancer was also seen, with a 9.4% progression rate for Photofrin plus omeprazole vs. 18.6% for omeprazole. Photofrin is currently approved for use in esophageal, lung and bladder cancer
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