FDA Approves New Indication for Lucentis

The US Food and Drug Administration (FDA) has approved Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR), in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10% of people with DR.

The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication. The FDA designates Breakthrough Therapy to a medicine if it is intended to treat a serious or life-threatening disease and if preliminary clinical research suggests it may provide substantial improvement on clinically significant endpoints over existing therapies. The FDA grants Priority Review to medicines that, if approved, would have the potential to provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

Lucentis was approved by the FDA for the treatment of DME in 2013. Lucentis has also been an important option for patients with wet age-related macular degeneration since 2006 and macular edema following retinal vein occlusion since 2010.

Lucentis is a vascular endothelial growth factor (VEGF) inhibitor 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. Lucentis was developed by Genentech. The company retains commercial rights in the US, and Novartis has exclusive commercial rights for the rest of the world.

Source: FDA and Roche

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