New diabetes drug receives approval for sale in Europe

Wed, 30 Nov 2011
The European Commission has given approval to saxagliptin, to be marketed under the brand name Onglyza, for use as a combination therapy by adult patients with type 2 diabetes to help improve their control of blood sugar levels.

Onglyza, which has been developed by pharma giants Bristol-Myers Squibb and AstraZeneca, was approved from Phase 3b 24-week data that showed Onglyza 5 mg added to insulin, with or without metformin, could substantially lower blood sugar levels as compared with a placebo added to insulin, with or without metformin.

It was also found that during the 28-week extension period of the study, Onglyza 5 mg added to insulin, with or without metformin, maintained a lowering of HbA1c levels from 24 to 52 weeks as compared with a placebo.

Onglyza is to be used in combination with drugs such as metformin, thiazolidinedione, sulphonylurea or insulin, if each of these is insufficient on their own to offer sufficient glycaemic control to patients. The approval of Onglyza in Europe provides another option for treating type 2 diabetes, particularly as a large number of patients will eventually have to use insulin to treat their condition.

However, it is advised that Onglyza should not be taken by people with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, and should not be seen just as an alternative to insulin.

Link to this page

Copy and Paste the following HTML into your page.

Join us