Boehringer Ingelheim and partner Eli Lilly are celebrating the news that regulators in Europe have given the green light to their once-daily type 2 diabetes pill Trajenta.
The firms have received marketing authorisation from the European Commission for Trajenta (linagliptin) to be used in combination with metformin and metformin plus sulphonylurea. It has also been approved for use as monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate.
Approval of the dipeptidyl peptidase-4 inhibitor is based on a clinical trial programme which involved some 6,000 adults. Boehringer's head of medicine, Klaus Dugi, noted that "observed improvements in glycaemic control have proved to be durable up to 52 weeks and effective for a wide range of adult patients, making linagliptin a reliable and efficacious treatment".
The company also quoted Anthony Barnett, emeritus professor of medicine at the University of Birmingham, UK, as saying that "unlike other DPP-4 inhibitors, linagliptin is primarily excreted unmetabolised via bile and gut, meaning no dose adjustment is needed in adult patients with declining kidney or liver function". This means that the drug is available at only one dose (5mg) which is "convenient for physicians, because one dose is the right dose for all adult patients".
Lilly got on board with Trajenta at the beginning of this year as the treatment is one of five diabetes drugs covered by an alliance which saw the US major make an initial payment of 300 million euros and up to 625 million euros to get joint rights to linagliptin and BI10773, a sodium-dependent glucose co-transporter-2 inhibitor, which is in Phase III.
Linagliptin will go up against Merck & Co's well-established DPP-4 inhibitor Januvia (sitagliptin) and Janumet (sitagliptin and metformin), as well as Bristol-Myers Squibb/AstraZeneca's Onglyza (saxagliptin) and Novartis' Galvus (vildagliptin). The Boehringer/Lilly drug was approved in the USA in May where it is marketed as Tradjenta.