Drug approval and launch for Novartis in China, where Quintiles expands

Swiss drug major Novartis (NOVN: VX) says it has 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.

In China, there are an estimated 300,000 new wet AMD patients per year, and as many as 75 million people have uncontrolled type 2 diabetes. The number of people with diabetes in China has nearly quadrupled in recent years, making it the country with the largest number of adults with diabetes in the world, noted Novartis.

Lucentis is the first licensed therapy in its class available to patients in China. The Chinese approval of Lucentis 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.