FDA grants Priority Review status for new drug for the treatment of diabetic retinopathy
Genentech, a San Francisco–based biotechnology pharmaceutical company, is one step closer to gaining approval for Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy. The U.S. Food and Drug Administration (FDA) recently announced it has agreed to file the company's supplemental Biologics License Application (sBLA) and grant Priority Review status for the drug treatment for diabetic retinopathy. Lucentis is a vascular endothelial growth factor (VEGF) inhibitor that is designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels, which can lead to vision loss. The drug has already been approved for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema. "Diabetes has emerged as a global epidemic, with 29 million people in the U.S. with diabetes at risk of diabetic eye disease," said Sandra Horning, chief medical officer and head of Global Product Development for Genentech. "We are committed to the treatment of serious eye diseases for patients with diabetes and pleased the FDA is moving forward in its consideration of Lucentis for diabetic retinopathy." The FDA confirmed it will make a decision on February 6, 2015. For more information, contact: Genentech Headquarters, 1 DNA Way, South San Francisco, CA 94080; phone: 800-626-3553 or 650-225-1000; website: www.gene.com.