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

December 30, 2015

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

"Type 2 diabetes is increasing at an alarming rate and we are proud to offer a new treatment option that could potentially help the millions of people with type 2 diabetes whose blood sugar is uncontrolled," said Albert Ros, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "When we introduce a new medicine to the marketplace, our goal is to improve patient care and we are hopeful that TRADJENTA will help do that."

The FDA approval of TRADJENTA 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. "TRADJENTA is the first regulatory approval of what we hope will be many new treatment options this alliance brings to the millions of Americans living with type 2 diabetes."

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

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.; Eli Lilly and Company