FDA approves expanded use of Boehringer and Lilly's Tradjenta

German family-owned drug major Boehringer Ingelheim and US partner and Eli Lilly (NYSE: LLY) said on Friday that the US Food and Drug Administration has approved a supplemental New Drug Application for Tradjenta (linagliptin) tablets for use as add-on therapy to insulin.

Tradjenta is a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, and can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes, such as metformin, sulfonylurea, pioglitazone or insulin.

Sold as Trajenta in Europe and Canada, this is the first drug to come to market under a collaboration on diabetes between Boehringer and Lilly signed in January 2011, which led to the dissolution of Lilly’s alliance with Amylin on Byetta and Bydureon and the eventual sale of the latter to Bristol-Myers Squibb. Linagliptin was approved by the FDA and the European Medicines in May 2011 and August, respectively (The Pharma Letters passim).