MSD diabetes compound gets positive EU opinion

Merck, Sharp and Dohme (MSD) has announced that Januvia (sitagliptin phosphate), its treatment for type two diabetes, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Commission (EC).

Januvia is an orally administered selective DPP-4 inhibitor taken once a day to enhance the incretin system in the body to lower blood sugar. The compound has been investigated for use in conjunction with metformin patients with type two diabetes to enhance glycemic control.

It has also been investigated as a monotherapy and an adjunctive therapy with PPAR agonists for those diabetes patients for whom use of thiazolidinedone or other PPAR agonists is appropriate.

“If the EC adopts the opinion, Januvial will be the first and only prescription medication in a new class of drugs known as DPP-4 inhibitors, which enhance the body’s own ability to lower blood sugar (glucose) when it is elevated,” the company reports.

MSD adds that the incidence of adverse affects following administration of Januvia were comparable to placebo.

In October 2006, Januvia was approved in the US as a monotherapy and adjunctive therapy for use with metformin or thiazolidinediones for the improvement of glucose control patients with type two diabetes.