Chinese Regulator Clears Novartis’s Lucentis for Treating Wet AMD

Company also launched antidiabetic Galvus in China.

China’s drug regulator cleared Novartis’ Lucentis® (ranibizumab) as a treatment for wet age-related macular degeneration. Novartis also confirmed the Chinese launch of its diabetes drug, Galvus® (vildagliptin), as an oral add-on therapy to metformin for patients with type 2 diabetes.

The firm says Lucentis is the first licensed therapy in its class to be cleared in China. Approval was based on clinical data including global and local Chinese clinical studies. The drug is a humanized therapeutic antibody fragment that blocks all biologically active forms of VEGF-A, increased levels of which occur in wet AMD and other ocular disorders such as diabetic macular edema (DME) and retinal vein occlusion (RVO).

Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to the drug in the U.S., and Novartis has exclusive rights in the rest of the world. Lucentis is currently licensed for the treatment of wet AMD in over 100 countries. Outside of China it is also approved in more than 50 countries for the treatment of visual impairment due to DME, and visual impairment due to macular edema secondary to RVO.

Galvus is approved in over 90 countries across Europe, Asia Pacific, Africa, and Latin America. Individual country approvals cover use of the drug for the treatment of type 2 diabetes either as a monotherapy, and/or and in combination with metformin, a sulphonylurea, a thiazolidinedione, or insulin.