AstraZeneca is on the verge of reaping more fruit from its diabetes collaboration with US group Bristol-Myers Squibb after European regulators issued a green light for the groups’ jointly developed Onglyza.

Specifically, Onglyza (saxagliptin) has been cleared to treat patients with type II diabetes in combination with diet and exercise and either metformin, a sulphonylurea or a thiazolidinedione when these drugs do not provide adequate glucose control alone.

Approval by the European Commission, which follows a regulatory nod by its peers across the Atlantic in August, was based on a comprehensive package of clinical data involving over 4,000 patients clearly demonstrating the drug’s ability to produce significant reductions across key measures of glucose control when it was added to these older treatments.

Onglyza belongs to a relatively new class of diabetes therapies called dipeptidyl peptidase-4 (DPP-4) inhibitors that work by enhancing pancreatic islet cell function - a fundamental defect in type 2 diabetes - to promote insulin secretion and inhibit glucagon production, resulting in reduced glucose production by the liver. Furthermore, it seems that DPP-4 inhibitors are less likely to cause weight gain - which can magnify the already raised risk of developing heart disease - than other therapies for the disease.

The drug is the product of a partnership between AZ and B-MS to develop and commercialise two diabetes agents - dapagliflozin and Onglyza - and analysts believe that both have the potential to obtain blockbuster status despite having to compete with Merck & Co’s established rival Januvia (sitagliptin), which hit the US market in October 2006 and has been available in Europe for around two and half years.

Fourth-quarter launch
According to AZ it expects to roll out Onglyza in Europe sometime during the fourth quarter, after which it could become an important addition to the fight against diabetes particularly as many patients are still failing to reach recommended levels of blood sugar despite pharmacological interventions, and at a time when the incidence of the disease is skyrocketing around the globe.

New figures published by UK charity Diabetes UK show that there were over 145,000 new cases of diabetes in the country alone over the last 12 months, and there is growing concern over how health bodies around the world will cope with the swell of patients in the coming years.

While a spokesman for AZ was unable to confirm to PharmaTimes World News what the National Health Service list price for Onglyza might be, he did stress that its cost would be similar to that of others in the gliptin class of diabetes drugs.