Novartis' Galvus gains EU support
Filed under: Type 2, Adult Onset, Drugs, Research
An advisory committee for the European Medicines Agency (EMEA) gave a thumbs up on type 2 diabetes drug Galvus. The EMEA's recommendations are usually endorsed by the European Commission within a few months.
Galvus, marketed by Swiss drugmaker Novartis, is a new oral anti-hyperglycemic agent of the DPP-4 class of drugs. Known as vildagliptin, it inhibits the inactivation of GLP-1 and GIP by DPP-4, allowing insulin secretion in the beta cells and suppression of glucagon from the islets of Langerhans.
In the United States, Galvus is awaiting Food and Drug Administration approval. The agency has delayed approval twice, requesting additional clinical data on vildagliptin, including proof the skin lesions and kidney impairments seen in an earlier animal study have not occurred in humans. The delays have carved a big market lead for Januvia, a similar drug marketed by Merck.
Galvus is one of Novartis' most important drugs under development. No wonder, it could potentially generate $1 billion or more in revenue. If only the same amount of money was spent on supportive diet and exercise programs for those at risk for type 2 diabetes. Photo by rodrigo senna at flickr.