FDA approves added indication for Genentech's Lucentis

8 February 2015
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The US Food and Drug Administration on Friday approved Swiss pharma giant Roche (ROG: SIX) subsidiary Genentech’s Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME).

The FDA granted Lucentis Breakthrough Therapy designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials. DME impacts nearly 750,000 Americans, about 10% of people with DR.

Already a blockbuster drug for Roche and Novartis in current indications

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