CHMP backs Boehringer-Lilly diabetes drug Trajenta
pharmafile | June 27, 2011 | News story | Sales and Marketing | Tradjenta, Trajenta, diabetes
Boehringer Ingelheim and Eli Lilly’s new type II diabetes drug Trajenta has been recommended for European approval.
It was given the green light by regulatory advisors at the CHMP, whose advice usually translates into a full approval within three months.
Trajenta (linagliptin) was recommended 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.
Prof Klaus Dugi, corporate senior vice president medicine, Boehringer Ingelheim said: “Type II diabetes is increasing at an alarming rate worldwide. We are proud that we may soon have the opportunity to offer a new treatment option from our own Boehringer Ingelheim research labs to the millions of European patients with type II diabetes whose blood glucose is not adequately controlled.”
Enrique Conterno, president of Lilly Diabetes, said: “Based on our comprehensive studies and the CHMP’s positive recommendation, we believe linagliptin can be an important new treatment option for patients with type II diabetes.”
The CHMP recommended Trajenta as a monotherapy in patients whose diabetes is inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.
The drug was also recommended for approval in combination with metformin and metformin + sulphonylurea, but should not be used in patients with type 1 diabetes or to treat diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.
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, meaning no dose adjustment is needed, even in patients with declining kidney or liver function.
It was launched in the US, where it is know as Tradjenta, earlier this month and is the most advanced drug in Boehringer’s diabetes collaboration with Lilly.
Signed in January 2011 this covers not just Trajenta but also another Boehringer oral diabetes drug (BI10773) and two of Lilly’s basal insulin analogues (LY2605541 and LY2963016).
Dominic Tyer
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