Eli Lilly and Boehringer Ingelheim have secured marketing approval for their fixed-dose combination drug Jentadueto for type 2 diabetes in the EU and have said it will be available across Europe soon.
Jentadueto combines the DPP-4 inhibitor linagliptin, which Boehringer and Lilly market as Trajenta in Europe (and as Tradjenta in the US), with the older generic drug metformin.
The new drug is an important line extension for Trajenta, which was approved a year ago in Europe to treat type 2 diabetes alongside metformin and sulphonylurea drugs. The fixed dose combination means that people with diabetes can take just one tablet twice a day to help control blood sugar.
Specifically, the European Commission approved Jentadueto for use alongside diet and exercise to improve glycaemic control in adults with type 2 diabetes who are inadequately controlled on their maximal tolerated dose of metformin alone, metformin and a sulphonylurea, or those already being treated with the combination of Trajenta and metformin given as separate doses, said Boehringer.
Jentadueto was cleared by the US Food and Drug Administration (FDA) earlier this year and the line extension is considered critical if Boehringer and Lilly's linagliptin franchise is to compete with the current crop of DPP-4 inhibitors, currently led by Merck & Co's Januvia (sitagliptin) and Janumet (sitagliptin and metformin).
Januvia/Janumet pulled in $4.7bn in sales last year for Merck and has got off to a strong start on 2012, with first quarter sales up more than 40 per cent year-on-year.
Meanwhile, Jentadueto is going up against two other DPP-4 inhibitors - Bristol-Myers/AstraZeneca's Onglyza (saxagliptin), and Novartis' Galvus (vildagliptin) - with 2011 sales of $684m and $677m in 2011.
Both saxagliptin and vildagliptin are already available in fixed-dose combinations with metformin, and Boehringer and Lilly are hoping that linagliptin's tolerability, along with no need for dose adjustment in patients with impaired liver or kidney function, will help drive uptake.
Lilly and Boehringer entered into an alliance on diabetes in January 2011 to co-develop and co-market four diabetes drugs, including linagliptin, Boehringer oral diabetes drug BI10773 and two of Lilly's basal insulin analogues, LY2605541 and LY2963016.