Boehringer Ingelheim and Eli Lilly have received Marketing Authorisation from the European Commission (EC) for its type 2 diabetes tablet Trajenta (linagliptin).
The EC has approved Trajenta in combination with metformin and metformin plus sulphonylurea after clinical trials involving approximately 6,000 adults showed it reduced haemoglobin A1c (HbA1c) levels.
Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, says Trajenta has been shown to be a “reliable and efficacious treatment” for type II diabetes.
The tablet has also been approved for use as monotherapy in patients who have not responded to diet and exercise alone, and for whom metformin is inappropriate.
Unlike other DPP-4 inhibitors, Trajenta is primarily excreted unmetabolised via bile and gut which means there is no dose adjustment required for adult patients that may have declining kidney or liver function.
Professor Anthony Barnett, Consultant Physician, Heart of England NHS Foundation Trust and Emeritus Professor of Medicine, University of Birmingham, says that with Trajenta only available at a single 5mg dose, it is “convenient for physicians”.
“The EU approval of linagliptin marks another major regulatory milestone for the Boehringer Ingelheim and Lilly alliance in diabetes,” said Enrique Conterno, President of Lilly Diabetes. “Linagliptin can be an important treatment option for people living with type II diabetes.”
Boehringer and Lilly began an alliance in January this year that centres on four pipeline compounds which represent several of the largest treatment classes in the field of diabetes.