EU Okays Combination Type 2 Diabetes Pill

May 29, 2012

May 29, 2012 (London, United Kingdom)— Advisors for the European Medicines Agency (EMA) last week paved the way for approval of a combination pill containing the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin and metformin hydrochloride (Jentadueto, Boehringer Ingelheim/Eli Lilly) for type 2 diabetes [1].

The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a "positive opinion" for the product for use alongside diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of linagliptin and metformin [2]. It is also indicated in combination with a sulfonylurea (ie, triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea.

A positive opinion from the CHMP is a prerequisite to pan-EU approval by the European Commission, which has 67 days from the date of the opinion to grant approval.

Jentadueto is designed to be taken as a single table twice daily and would be available in two strengths in the EU: 2.5-mg linagliptin/850-mg metformin and 2.5 mg/1000 mg. The combination product was approved by the US FDA in January.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.