Takeda’s new diabetes drug Vipidia debuts in UK

Japan’s largest drugmaker Takeda Pharmaceuticals (TYO: 4502) this morning launched its new type 2 diabetes drug Vipidia (alogliptin) in the UK, its third European launch following Denmark and Switzerland.

Vipidia (also brand named Nesina) is a new DPP-4i for the management of type 2 diabetes, launched in the UK with cardiovascular (CV) safety outcomes. Vipidia and the fixed dose combination product Vipdomet (alogliptin and metformin) are now available in the UK. Vipidia is licensed for the treatment of type 2 diabetes mellitus in adults aged 18 years and older to improve glycemic control in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycemic control.

The granting of the licence by the European Medicines Agency (The Pharma Letter September 24, 2013) is based on the results of a robust clinical trial program including over 14,800 patients, says Takeda. CV disease accounts for 52% of fatalities in people with type 2 diabetes. In addition, no new safety signals were identified for Vipidia in EXAMINE. The results of the EXAMINEsafety trial of up to 40 months met its primary endpoint, demonstrating that Vipidia does not increase CV risk in type 2 diabetes patients at high-risk for major adverse cardiac events (MACE) due to a recent acute coronary syndrome (ACS). Nesina was approved in the USA in January 2013 and was launched there in the summer of that year (TPL June 20, 2013).