Novartis receives approval for Lucentis and launches Galvus in China
Novartis announced that it received regulatory approval in China from the State Food and Drug Administration (SFDA) for Lucentis® (ranibizumab) to treat wet (neovascular) age-related macular degeneration (AMD), and is launching Galvus® (vildagliptin), an oral treatment for patients with type 2 diabetes approved in China as an add-on to metformin, the standard of care .
Lucentis is the first licensed therapy in its class available to patients in China. The approval of Lucentis in China for the wet AMD indication is based on comprehensive clinical data and experience, including global and local Chinese clinical studies. Since its launch, Lucentis has become the standard first line therapy in the treatment of wet AMD and, to date, there are more than 1,000,000 patient-treatment years of exposure for Lucentis.
Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A (VEGF-A). Increased levels of VEGF-A are seen in wet AMD and other ocular diseases such as diabetic macular edema (DME) and retinal vein occlusion (RVO). Lucentis has been designed, developed and formulated specifically for use in o
Galvus (vildagliptin) is now available in China. Vildagliptin is an oral treatment for patients with type 2 diabetes and is approved in China as an add-on to metformin, the standard of care.
Approval was based on a 24-week, double-blind, randomized, parallel-group study which compared the effects of vildagliptin versus placebo in Chinese patients with type 2 diabetes already receiving metformin (n=438). Vildagliptin (50mg twice a day) achieved a statistically significant reduction in blood sugar levels. Incidence of serious adverse events, including hypoglycemia was low, and vildagliptin was generally demonstrated to be well-tolerated.
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