Merck & Co is celebrating after getting the backing of European Union drug regulators to market Januvia, its promising new drug for the treatment of diabetes.
Januvia (sitagliptin), the first in a new class of drugs called dipeptidyl peptidase-4 inhibitors, has received a positive opinion for treating type-2 diabetes from the Committee for Medicinal Products for Human Use (CHMP) and could get full approval from the European Medicines Agency (EMEA) as soon as April. The US Food and Drug Administration gave Januvia the green light in October as monotherapy and as add-on therapy to either metformin or thiazolidinediones to improve blood glucose control in patients with type 2 diabetes, when diet and exercise is not enough.
The positive noises coming out of Europe mean that Merck has stolen a further march on Novartis whose rival DPP-4 inhibitor Galvus (vildagliptin) was only filed with the EMEA in August. The situation is worse for the Swiss firm in the USA as the FDA requested additional information on Galvus at the end of 2006 and a verdict is not expected before next month. Merck, however, added that it also expects to hear from the FDA in March about its New Drug Application for Janumet, which combines Januvia and metformin.
The DPP-4 inhibitor class has been touted by analysts as an extremely lucrative one, as such drugs seem less likely to cause weight gain, which can compound diabetics' already-elevated risk of developing heart disease, than other treatments for the disease.
Extended use for Prevenar and Xyrem
The CHMP also backed extending the use of Wyeth's pneumococcal vaccine Prevenar to immunise small children from two months up to five years against otitis media. Prevenar is currently used to immunise children against sepsis, meningitis and bacteraemic pneumonia. The committee also recommended that the EMEA grant marketing authorisation for UCB’s Xyrem (sodium oxybate) to treat narcolepsy with cataplexy in adults.