US approval for Boehringer’s diabetes drug Tradjenta
pharmafile | May 3, 2011 | News story | Sales and Marketing | Boehringer Ingelheim, Tradjenta, diabetes, lilly
Tradjenta, the once-daily oral type II diabetes treatment developed by Boehringer Ingelheim, has been approved by US regulators.
The FDA says DPP-4 inhibitor Tradjenta (linagliptin) can be used at 5mg as monotherapy or in combination with metformin, sulfonylurea or pioglitazone.
The drug, which is in the same class as AZ/BMS’ Onglyza and Merck & Co’s Januvia, is the first of its kind to be approved at one dosage strength, even for patients who suffer from kidney or liver impairment.
“Many people with type II diabetes are not able to control their blood sugar with diet and exercise alone and may also require one or more medications,” said John Gerich, professor at the University of Rochester School of Medicine.
“The FDA approval of Tradjenta is exciting because there is only one dose to remember for all patients, regardless of kidney or liver impairment,” he added.
Around 220 million people worldwide have diabetes, with type II cases accounting for an estimated 95% of these.
Tradjenta lowers blood sugar in a glucose-dependent manner by increasing incretin levels, which raise insulin levels after meals and throughout the day. Phase III data presented last year showed Tradjenta achieved this with no safety issues.
In a trial involving 4,000 patients, reductions in hemoglobin (A1C) levels of up to 0.7% more than placebo were seen with Tradjenta as monotherapy.
In combination with metformin, sulfonylurea, and metformin plus sulfonylurea, A1C reductions were 0.6, 0.5, and 0.6% respectively, compared to placebo. Tradjenta plus pioglitazone resulted in A1C reductions of 0.5%.
On its own and in combination, the drug also reduced patients’ fasting plasma glucose (FPG) compared to placebo, and it produced significant reductions in two-hour post-prandial glucose (PPG) levels as monotherapy and in combination with metformin.
Tradjenta has not been studied in combination with insulin.
Boehringer signed a multi-million dollar collaboration in January with Eli Lilly to develop and commercialise a mid- to late-stage pipeline of four diabetes compounds, of which linagliptin is one.
The others are Boehringer’s oral diabetes agent BI10773 and Lilly’s basal insulin analogues LY2605541 and LY2963016.
The agreement with Lilly also gives Boehringer an option to co-develop and co-commercialise Lilly’s anti-TGF-beta monoclonal antibody for kidney disease related to diabetes.
“Our alliance with Boehringer Ingelheim represents one of the most robust diabetes pipelines in the pharmaceutical industry,” said Enrique Conterno, president of Lilly Diabetes.
“Tradjenta is the first regulatory approval of what we hope will be many new treatment options this alliance brings to the millions of Americans living with type II diabetes.”
Adam Hill
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