Jentadueto linagliptin/metformin regulatory update
On Dec. 18, 2013, EMA's CHMP recommended approval of a Type II variation from Boehringer Ingelheim to expand the label of Jentadueto to include treatment of Type II diabetes in combination with insulin as an adjunct to diet and exercise to improve glycemic control in adults when insulin and metformin alone do not provide adequate control. Jentadueto is approved to improve glycemic control in patients inadequately controlled on metformin alone or those already being treated with Tradjenta linagliptin, a xanthine-based dipeptidyl peptidase-4 (DPP-4) inhibitor, in combination with metformin. Jentadueto is also approved in combination with a sulfonylurea in patients inadequately controlled with metformin and a sulfonylurea. Jentadueto combines linagliptin and metformin. ...