Genentech gains FDA panel backing for Lucentis to treat DME
US biotech firm Genentech, a subsidiary of Swiss drug major Roche (ROG: SIX), revealed last week that the US Food and Drug Administration’s Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (10-0) to recommend approval of the 0.3mg dose of Lucentis (ranibizumab injection) for treatment of diabetic macular edema (DME). The majority of the advisory panel (eight to two) also recommended the 0.5mg dose.
The FDA is expected to make a decision regarding the supplemental Biologics License Application (sBLA) for Lucentis in DME by August 10, 2012.
If approved, first drug cleared for DME
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