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Merck's Januvia gets EU recommendation

25 January, 2007

U.S. drug firm Merck said Thursday its type 2 diabetes drug Januvia has been recommended for approval in the European Union.

The company said it has received a positive opinion from the Committee for Medicinal Products for Human Use -- part of the EU's European Medicines Evaluation Agency -- which recommended the first-in-class DPP-4 inhibitor be approved in Europe for type 2 diabetes.

Merck said it expects full marketing approval for Januvia in early April.

The diabetes treatment is currently approved in 11 other countries, including the United States and Mexico.

In October 2006 the U.S. Food and Drug Administration cleared Januvia as a monotherapy and as add-on therapy to either metformin or thiazolidinediones to improve blood-sugar control in type 2 diabetes patients when diet and exercise are not enough.

Januvia works by enhancing the body's own ability to lower blood sugar when it is elevated, Merck said.

Source: http://www.upi.com/HealthBusiness


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