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PhotoCure Hexvix "not approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

PhotoCure's cytoscopy agent Hexvix (hexaminolevulinate) for bladder cancer diagnosis is "not approvable" April 19. "FDA has requested additional analyses and information," the Norwegian firm says April 20. PhotoCure plans to initiate a discussion with FDA that will take place "over the coming months." The firm is currently conducting a Phase III study of Hexvix in the EU and U.S. "This study is not part of the initial application and may provide useful supplementary clinical data," PhotoCure notes. The trial is slated to end in 2007. In January, PhotoCure inked a licensing agreement with GE for marketing and distribution outside the U.S. (1Pharmaceutical Approvals Monthly January 2006, p. 42). The firms launched Hexvix in Europe in early April...

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