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Genentech Lucentis priority review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genentech's BLA for its wet age-related macular degeneration treatment Lucentis (ranibizumab) is granted a priority review at FDA, giving the VEGF antibody a June 29 user fee goal date. Genentech's submission includes a head-to-head trial with Novartis/QLT's photodynamic therapy Visudyne (verteporfin). Genentech has referred to Lucentis as the first wet AMD treatment to show a clinical benefit over PDT in a head-to-head study setting (1Pharmaceutical Approvals Monthly June 2005, p. 12). In conjunction with the priority review designation, Genentech announced preliminary, two-year data from its Phase III MARINA study showing improvement at two years...

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