Bristol-Myers Squibb Company and AstraZeneca today announced that their marketing authorisation application for saxagliptin (ONGLYZA) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of Type 2 diabetes in adults as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea.
The positive opinion was reached after the CHMP reviewed data from a comprehensive clinical development programme that included six core phase III trials assessing the safety and efficacy of saxagliptin as a once daily therapy. These involved 4,148 patients with Type 2 diabetes, including 3,021 patients treated with saxagliptin.
Saxagliptin belongs to the class of drugs known as dipetidyl peptidase-4 (DPP-4) inhibitors (also known as gliptins). These are designed to enhance the body’s ability to decrease elevated levels of blood sugar (glucose) by increasing the body’s natural hormones, incretins, which increase insulin production and have other beneficial effects in the process of glucose metabolism.
This application to the CHMP is for use as a once daily 5mg dose in adult patients with Type 2 diabetes mellitus to improve glycaemic control:
- in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;
- in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; or
- in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate.
The CHMP’s positive opinion on saxagliptin will now be reviewed by the European Commission which has the authority to approve medicines for the European Union. Bristol-Myers Squibb and AstraZeneca expect the European Commission to issue its decision on a Marketing Authorisation for this Type 2 diabetes investigational drug in the European Union in the coming months.
In a joint statement, Frédéric Duchesne, General Manager, Bristol-Myers Squibb UK and Dr Guy Yeoman, Medical Director, AstraZeneca UK commented: “This positive opinion for saxagliptin represents a significant step forward for the Bristol-Myers Squibb and AstraZeneca diabetes collaboration as we work towards becoming a key partner in the diabetes community. We are excited at the prospect of being able to bring saxagliptin to the UK to help provide another option for the many people with Type 2 diabetes who are not achieving optimal disease control with the current treatments available. Through our focus on patient care and our collaborative approach to addressing problems such as adequate glycaemic control, we hope to play an important role in improving the outcomes for people with Type 2 diabetes”.