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December 10, 2013

Scottish Medicines Consortium approves Onglyza for triple therapy for type 2 diabetes patients

The Scottish Medicines Consortium (SMC) has accepted AstraZeneca and Bristol-Myers Squibb's DPP-4 inhibitor Onglyza (saxagliptin) for restricted use as part of a triple oral therapy treatment regimen for type 2 diabetes within NHS Scotland.

The Scottish Medicines Consortium (SMC) has accepted AstraZeneca and Bristol-Myers Squibb’s DPP-4 inhibitor Onglyza (saxagliptin) for restricted use as part of a triple oral therapy treatment regimen for type 2 diabetes within NHS Scotland.

The drug is recommended in type 2 diabetes adult patients aged 18 years and older in combination with metformin, plus a sulphonylurea when the regimen alone, when diet and exercise does not provide adequate blood glucose control.

In Scotland, there are 221,500 people with diagnosed type 2 diabetes and possibly a further 43,000 undiagnosed.

Each year, it is expected that around 16,800 new cases of type 2 diabetes are diagnosed in Scotland and 12% of type 2 diabetes patients are currently taking a triple therapy regimen, with 40% of these taking a combination of metformin, a sulfonylurea and a DPP-4 inhibitor.

"We recognise there is a need for a range of medication options to tailor treatment to individual patient needs, and our type 2 diabetes treatment portfolio has several different classes of medicine to help patients manage this complex condition."

North Berwick Group Practice GP Kevin Fernando said ensuring that patients’ treatment regimens are tailored to their individual needs is an important step in successfully managing type 2 diabetes.

"Some type 2 diabetes patients require multiple medications to manage their disease, and so the SMC decision to approve the use of saxagliptin as part of a triple-therapy regimen, in addition to its existing approval for dual therapy, provides increased choice for clinicians and patients in Scotland when deciding on the most appropriate treatment," Fernando said.

The SMC triple therapy approval follows the triple therapy licence granted by the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in January 2013.

Bristol-Myers Squibb general manager Amadou Diarra said: "We recognise there is a need for a range of medication options to tailor treatment to individual patient needs, and our type 2 diabetes treatment portfolio has several different classes of medicine to help patients manage this complex condition."

AstraZeneca president of UK marketing company Lisa Anson said: "We welcome the additional recommendation from the SMC for saxagliptin’s use in triple therapy."

Onglyza (saxagliptin) is designed to improve blood glucose (glycaemic control) by reducing fasting and postprandial blood glucose concentrations in patients with type 2 diabetes.

The recommended dose of saxagliptin is 5mg once daily and it should be reduced to 2.5mg once daily in patients with moderate or severe renal impairment.

The drug should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

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