US approval for Onglyza
pharmafile | August 6, 2009 | News story | Research and Development, Sales and Marketing | AZ, BMA, diabetes
Adult type II diabetes treatment Onglyza has been approved by the US Food and Drug Administration.
Co-marketed by AstraZeneca and Bristol-Myers Squibb, the dipeptidyl peptidase-4 (DPP-4) inhibitor Onglyza (saxagliptin) helps patients control their blood sugar.
The companies have been jointly working on the once-daily drug's development for more than two year and, after last year submitting it for approval in Europe and the US, are now presenting it with great fanfare by the companies.
While it has not been studied in combination with insulin, Onglyza can be used with other anti-diabetic medications such as metformin, sulfonylureas or thiazolidinediones.
Indicated as an adjunct to diet and exercise, it can also be taken as a monotherapy to reduce glycosylated hemoglobin (A1C) levels.
"Nearly half of adult patients remain uncontrolled on their current treatment regimen and may thus require additional medications," said Elliott Sigal, president of research and development at BMS.
"Our ongoing clinical trial programme has demonstrated that Onglyza showed improved A1C control both in combination and monotherapy settings," he added.
In the same class as MSD's Januvia (sitagliptin) and Novartis' Galvus (vildagliptin), it also threatens other older oral diabetes treatments such as GSK's Avandia (rosiglitazone).
DPP-4s are as effective at lowering blood sugar levels, without side-effects such as weight gain.
"Type II diabetes is a daily challenge for adult patients and physicians," said AstraZeneca chief executive David Brennan.
"Physicians and adult patients with type II diabetes [now] have an important new treatment to help improve glycemic control."
DPP-4 inhibitors affect incretins, the hormones that bring down blood sugar levels by increasing the body's utilisation of sugar.
This is achieved by increasing insulin production in the pancreas and reducing the liver's production of glucose.
Onglyza received a positive opinion from the Committee for Medicinal Products for Human Use last month.
In the UK, Onglyza is due to be launched before the end of 2009 with London-based healthcare PR agency Virgo Health handling the account.
Earlier this year, research funded by AstraZeneca revealed that UK diabetes rates have risen dramatically and are growing at a faster rate than in the US.
Linked to obesity, type II diabetes comes with long-term complications affecting many parts of the body.
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