Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The European Commission (EC) has granted marketing authorization approval to Boehringer Ingelheim and Eli Lilly for linagliptin 5mg film-coated tablets as a type 2 diabetes treatment.
Subscribe to our email newsletter
The EC approval has been granted for linagliptin in combination with metformin and metformin plus sulfonylurea.
The product will be marketed under Trajenta trade name in Europe.
The approval was backed by the results clinical trial program which included around 6,000 adults with type 2 diabetes.
In two monotherapy studies, linagliptin showed a mean difference in A1C from placebo of -0.6 to -0.7%.
Boehringer Ingelheim Medicine corporate senior vice president Klaus Dugi said the Phase III clinical trial program has demonstrated efficacy with linagliptin in the treatment of adults with type 2 diabetes.
"We are delighted that linagliptin will soon be available to patients across Europe," Dugi said.