US FDA clears Boehringer and Lilly's diabetes drug Tradjenta

The US Food and Drug Administration has approved Tradjenta (linagliptin), for use along with diet and exercise to lower blood sugar in adults with type 2 diabetes. The drug comes from the stable of German independent drug major Boehringer Ingelheim and will be commercialized with US partner Eli Lilly (NYSE: LLY).

"This approval provides another treatment option for the millions of Americans with Type 2 diabetes," said Mary Parks, Director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, noting that “it is effective when used alone or when added to existing treatment regimens.”

Tradjenta will compete in a US diabetes drug market valued at some $16.9 billion last year by IMS Health, where Merck & Co’s Januvia/Janumet (sitagliptin) franchise has a significant stake, garnering global sales of around $3.34 billion in 2010 and nearly $1 billion in the first quarter of this year.