Onglyza cleared for use with insulin
pharmafile | November 29, 2011 | News story | Sales and Marketing | AstraZeneca, Merck, Onglyza, diabetes, insulin
European regulators have approved a licence extension for Bristol-Myers Squibb and AstraZeneca’s type II diabetes treatment Onglyza.
The oral DPP-4 inhibitor can now be used as combination therapy with insulin, with or without metformin, to improve glycaemic control.
Onglyza (saxagliptin) was previously licensed to only treat type II diabetes patients keep their blood sugar levels low in combination with metformin, sulphonylurea or thiazolidinedione, when each of these alone (plus diet and exercise) was not enough.
The drug can now be used in more advanced cases when patients must use insulin to manage their blood sugar levels.
“It is important that anti-diabetic treatments can be used with insulin to help patients who are inadequately controlled on their current regimen,” said Brian Daniels, BMS senior vice president, global development and medical affairs.
The new approval was based on phase 3b 24-week data showing that Onglyza and insulin significantly reduced blood sugar levels ( HbA1c) versus placebo plus insulin.
In the 28-week extension period of the study, the combination maintained reductions of HbA1c from 24 to 52 weeks compared to placebo.
Howard Hutchinson, chief medical officer of AstraZeneca, said this combination therapy gives doctors another option to help patients manage what is a chronic and progressive disease.
Such extensions are also important for the companies in a competitive market: Merck & Co’s Januvia (sitagliptin) and Boehringer Ingelheim and Eli Lilly’s Trajenta (linagliptin) are in the same class.
In August Trajenta was approved Europe – the first of its kind to be approved at one-dosage strength, even for patients who suffer from kidney or liver problems. Onglyza can be used to treat moderate or severe renal impairment, but only at half its normal 5mg dose.
The FDA approved Merck’s Juvisync, a combination of Januvia and its anti-cholesterol brand Zocor (simvastatin) in July.
This is the first time such products have been put together as a once-daily treatment for patients who need to lower both blood sugar and cholesterol.
Adam Hill
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