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Novartis AMD drug receives Chinese approval

Novartis has received the China State Food and Drug Administration's (SFDA) approval for Lucentis (ranibizumab) as a treatment for wet (neovascular) age-related macular degeneration (AMD).

Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A (VEGF-A).

Lucentis has been formulated specifically for use in ocular disease with the aim of stabilizing and improving visual acuity in these patients.

The approval of Lucentis is based on the clinical data and experience, including global and local Chinese clinical studies.

Novartis has also launched Galvus (vildagliptin), an oral treatment for patients with type 2 diabetes as an add-on to metformin, in China.

Galvus (vildagliptin) was approved 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).

Novartis Pharmaceuticals Division head David Epstein said they bring Lucentis and Galvus to patients and physicians in China and support the achievement of the Chinese government’s public health goals.