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No FDA red flags, but Genentech may need DMO for Lucentis to stay a player

This article was originally published in Scrip

Executive Summary

US FDA staff analysts are largely supportive of the application from Roche's Genentech unit to add a new indication to its ophthalmic anti-VEGF antibody Lucentis (ranibizumab). The agency's advisory board of outside experts will on July 26 consider whether the drug should be approved as a treatment for diabetic macular oedema (DMO). The staff analysts from the division of transplant and ophthalmic products note that Lucentis, approved for treatment of wet age-related macular degeneration (AMD) and macular oedema following retinal vein occlusion, has been on the US market since June 2006 and "no postmarketing data or experience as been submitted to the division which affects the safety or efficacy of the product."



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