Hello Fellows:

"Sitagliptin/Pioglitazone Combo Application Withdrawn in EU".

November 14, 2011 — Merck Sharp & Dohme Inc. has withdrawn its marketing authorization application for sitagliptin/pioglitazone (Janacti), according to an announcement today from the European Medicines Agency (EMA).

Sitagliptin/pioglitazone is formulated as 100/30-mg and 100/45-mg fixed-dose combination tablets. In the official letter, the company stated that it is basing its decision to withdraw the application on "a review of the regulatory and commercial prospects for the fixed-dose combination product."

No ongoing clinical trials are underway with this agent.

A Q&A document about the decision, in addition to the withdrawal letter from the company, will be posted after the next meeting of The Committee for Medicinal Products (CHMP) for Human Use on November 14-17.

Sitagliptin/pioglitazone was intended to be used for treating adult patients with type 2 diabetes mellitus.

Sitagliptin (Januvia, Merck & Co, Inc.) is a dipeptidyl peptidase-4 inhibitor, and pioglitazone (Actos, Takeda Pharmaceutical Co Ltd.) is a thiazolidinedione and an agonist for peroxisome proliferator activated receptor-gamma. Both agents are indicated individually as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Any comments?

All Best,

Joey