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Boehringer Ingelheim, Eli Lilly receive FDA approval for linagliptin to treat type 2 diabetes

October 02, 2017

"Type 2 diabetes is increasing at an alarming rate and we are proud to offer people in the United States a new treatment option from our Boehringer Ingelheim research laboratories that could potentially help the millions of patients with type 2 diabetes whose blood sugar is not adequately controlled," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "When we introduce a new medicine, our goal is to improve patient care and we are confident that linagliptin will help to achieve that."

Adverse reactions reported in greater than or equal to five percent of patients treated with linagliptin and more commonly than in patients treated with placebo included nasopharyngitis. Hypoglycaemia was more commonly reported in patients treated with the combination of linagliptin and sulphonylurea compared with those treated with the combination of placebo and sulphonylurea. The incidence of hypoglycaemia was similar to placebo when linagliptin was administered as monotherapy or in combination with metformin or pioglitazone. Pancreatitis was reported more often in patients randomized to linagliptin (one per 538 person years versus zero in 433 person-years for comparator).

Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.

The FDA approval of linagliptin marks the first regulatory milestone since the formation of the Boehringer Ingelheim and Eli Lilly and Company worldwide diabetes alliance in January 2011. The alliance leverages the collective scientific expertise and business capabilities of two leading research-driven pharmaceutical companies to address patient needs arising from the growing global diabetes epidemic.

"Our alliance with Boehringer Ingelheim represents one of the most robust diabetes pipelines in the pharmaceutical industry," said Enrique Conterno, President of Lilly Diabetes. "Linagliptin is the first regulatory approval of what we hope will be many new treatment options this alliance brings to the millions of people living with type 2 diabetes."

The overall clinical development programme for linagliptin tablets consists of 30 studies completed, underway or planned. Linagliptin is currently under regulatory review in the EU and Japan.

Source: Boehringer Ingelheim