European regulators on Thursday approved Eli Lilly and Boehringer Ingelheim's oral, once-daily drug Trajenta (linagliptin) for the treatment of adults with type 2 diabetes. The DPP-4 inhibitor, which is one of several diabetes agents being developed under an agreement reached between the companies in January, was authorised earlier this year in the US, where it is marketed as Tradjenta.
Eli Lilly and Boehringer Ingelheim said the European Commission cleared Trajenta for use in combination with metformin and metformin plus sulphonylurea in people with type 2 diabetes. The agent was also authorised for use as a monotherapy in patients inadequately controlled by diet and exercise and for whom metformin is inappropriate.
The companies noted that the approval was based on clinical trial data for approximately 6000 adults with type 2 diabetes. According to the drugmakers, studies showed that Trajenta "is efficacious with a favourable safety and tolerability profile, reducing haemoglobin A1c levels by a mean of -0.6 to -0.7 percent" compared to placebo. "Observed improvements in glycaemic control have proved to be durable up to 52 weeks and effective for a wide range of adult patients," remarked Klaus Dugi, Boehringer Ingelheim's corporate senior vice president of medicine.
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