EU Okays Combination Type 2 Diabetes Pill

Disclosures

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.

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