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news.Merck & Co.'s treatment for patients with type 2 diabetes Januvia, has received a positive opinion from the European Medicines Evaluation Agency, regarding its approval in Europe.
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Following the conclusion of the review, the opinion for Januvia will be transmitted to the European Commission (EC). If the EC adopts the opinion, Januvia will be the first and only prescription medication in a new class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors, which enhance the body’s own ability to lower blood sugar when it is elevated.
Januvia is currently approved in eleven countries including the US and Mexico. The FDA has already approved Januvia as a monotherapy and as add-on therapy to either metformin or thiazolidinediones.
Marketing authorization from the European Commission is expected in early April after the adoption of the opinion.
The positive opinion in the EU was based on a review of comprehensive data supporting the efficacy and safety and tolerability profile of Januvia.