Boehringer-Lilly’s Trajenta wins European approval
pharmafile | August 26, 2011 | News story | Sales and Marketing | Tradjenta, Trajenta, diabetes
Boehringer Ingelheim and Eli Lilly’s new type II diabetes drug Trajenta has been approved Europe.
The European Commission backed Trajenta (linagliptin), an oral DPP-4 inhibitor, in combination with metformin and metformin plus sulphonylurea.
The drug was also approved for use as a monotherapy in patients inadequately controlled by diet and exercise alone, and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.
Boehringer signed a multi-million dollar collaboration in January with Lilly to develop and commercialise a mid- to late-stage pipeline of four diabetes compounds, of which Trajenta is one.
The drug, which is in the same class as AstraZeneca and BMS’ Onglyza and Merck’s Januvia, is the first of its kind to be approved at one-dosage strength in Europe, even for patients who suffer from kidney or liver impairment.
Its purpose is to help reduce blood sugar levels in type II diabetics in combination with healthy eating and regular exercise.
Professor Klaus Dugi, corporate senior VP of medicine at Boehringer, said: “The phase III clinical trial programme has demonstrated the meaningful efficacy provided by linagliptin in the treatment of type II diabetes.
“Observed improvements in glycaemic controls 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 for type II diabetes.”
Trajenta was approved on the strength of trials showing it reduced blood sugar levels by as much as 0.7% compared to placebo, and by up to 0.6% when added to the treatment of patients whose diabetes was inadequately controlled on metformin or metformin plus sulfonylurea.
Enrique Conterno, president of Lilly Diabetes, said: “The EU approval of linagliptin marks another major regulatory milestone for the Boehringer Ingelheim and Lilly alliance in diabetes.
“Linagliptin can be an important treatment option for adults living with type II diabetes,” he added.
The European approval follows on from the drug’s June launch in the US, where it is licensed under the brand name Tradjenta as a 5mg monotherapy, or in combination with metformin, sulfonylurea or Takeda’s Actos.
Ben Adams
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