Novartis’ new type 2 diabetes treatment Galvus has been accepted for review by the US Food and Drug Administration and a verdict should be forthcoming by early 2007.
Galvus (vildagliptin) could be the first in a new class of drug for diabetes called DPP-4 inhibitors, which are thought to offer advantages over existing treatments in terms of their side effects. Novartis says Galvus does not cause the weight gain seen with other oral diabetes drugs such as the sulfonylureas, a profile which could help it achieve sales in excess of $1 billion a year.
A rapid review in the USA is crucial for Novartis if it is keep up with rival Merck & Co, which filed for approval of its own DPP-4 inhibitor, Januvia (sitagliptin), in the USA last month.
Novartis was earlier thought to be in the lead in the race to bring a DPP-4 inhibitor to market, but was leapfrogged by Merck. The market for these drugs could be in the region of $3 billion in the USA alone, according to Morgan Stanley, assuming they win a half share of the market for sulfonylureas. Both GlaxoSmithKline and Bristol-Myers Squibb are also working on drugs in this class.
In a statement, Novartis said it remains on track to submit Galvus for approval later in 2006.