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GENENTECH SUBMITS BLA FOR LUCENTIS
Genentech has submitted a biologics license application (BLA) to the FDA for the use of Lucentis (ranibizumab) in the treatment of neovascular wet age-related macular degeneration (AMD). Lucentis is the first therapy for wet AMD to have shown improved vision in two pivotal Phase III trials and demonstrated a clinical benefit over verteporfin (Visudyne) photodynamic therapy in a head-to-head clinical trial.
The BLA submission is based on one-year clinical data on the efficacy and safety of Lucentis from two pivotal Phase III trials, ANCHOR and MARINA, as well as one-year clinical data from the Phase I/II FOCUS trial
KEYWORDS Drug Pipeline Alert
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