The US Food and Drug Administration has agreed to review Merck & Co’s application to market its experimental diabetes drug, Januvia (sitagliptin phosphate), placing the firm ahead of the pack in the race to get the first agent approved in this new class of type 2 diabetes therapies.
According to media reports, the filing puts Merck up to six months ahead of Swiss drug giant Novartis, which is also working on a submission for a similar drug. Thus, if it gets the go-ahead, Januvia will be the first in a novel class of oral dipeptidyl peptidase-4 (DPP-4) inhibitors, which work by boosting the body's own ability to reduce blood sugar.
Importantly, clinical studies indicate that Januvia is not associated with weight gain from baseline, and the incidence of hypoglycemia is similar to placebo. The most common side effects reported were stuffy or runny nose and sore throat, headache, diarrhoea and joint pain. "Based on our clinical studies, we believe Januvia represents a new and different approach to the treatment of type 2 diabetes," commented Richard T Clark, Chief Executive Officer and President of Merck.
Merck expects a decision from the FDA by mid-October and says it is also moving forward as planned with filings in countries outside the USA.
According to the firm, almost 21 million people in the USA, or 7% its population, have diabetes, with type 2 accounting for 90%-95% of the cases. Worryingly, less than 50% of adult diabetics achieve the American Diabetes Association target level of glucose control, so the need for new effective treatments is urgent. Estimates already put the number of diabetics worldwide at 194 million, and this figure could cap 333 million by 2025.