Trajenta added to insulin recommended in Europe
pharmafile | September 26, 2012 | News story | Sales and Marketing | Boehringer Ingelheim, Trajenta, diabetes
The CHMP has recommended that Boehringer Ingelheim and Eli Liily and Co’s diabetes brand Trajenta should be approved as add-on therapy to insulin in adults with type 2 diabetes.
The positive opinion from the European Medicines Agency’s medicinal committee suggests the combination should be used with insulin, with or without metformin, when the previous regimen with diet and exercise does not provide adequate glycaemic control.
DPP-4 inhibitor Trajenta (linagliptin) was approved by the EMA last year as a monotherapy in patients whose blood sugar level is inadequately controlled by diet and exercise and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.
The CHMP based its new opinion on data from various trials, including one phase III study which showed that adding Trajenta to insulin produced better glucose control than insulin alone, without an additional risk of hypoglycaemia after 24 weeks.
“Many patients with type 2 diabetes taking insulin require additional medication for adequate blood glucose control,” said Klaus Dugi, Boehringer’s corporate senior vice president medicine.
Boehringer launched Trajenta in the UK last year, priced to match match Merck’s blockbuster DPP-4 inhibitor Januvia (sitagliptin), its closest rival.
But Trajenta differs from Januvia in that it can be given to patients with renal impairment – which affects around two-thirds of diabetes patients – without having to adjust their dose, and Boehringer says this gives its brand the edge.
Trajenta is also approved with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control, and with a sulphonylurea and metformin when diet and exercise plus dual therapy do not provide a good control of sugar levels.
An estimated 366 million people worldwide have diabetes, with type 2 accounting for 90% of all cases.
Boehringer and Lilly said last year that they wouldn’t launch Trajenta in Germany, even though it is Europe’s largest pharma market, because they didn’t believe that the German government’s newly-introduced pricing system would justly reward the drug.
Adam Hill
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