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Scottish agency approves Lilly's diabetes drug

IndianapolisThursday, July 12, 2007, 08:00 Hrs  [IST]

Eli Lilly and Company and Amylin Pharmaceuticals, Inc. welcomed the recent decision by the Scottish Medicines Consortium (SMC) on the use of Byetta (exenatide) in Scotland. The decision states that exenatide is restricted for use in National Health Service (NHS) Scotland for the treatment of type 2 diabetes mellitus in combination with metformin and/or sulphonylureas in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. Exenatide has shown non-inferiority to two insulin regimens with which it has been compared and has a beneficial effect on weight. It is restricted to use as an alternative to insulin in patients who have failed treatment on metformin and/or sulphonylureas and in whom insulin would be the next treatment option. "Exenatide is the first incretin mimetic to be appraised by the SMC," said Andrew Hotchkiss, General Manager at Lilly UK. "Diabetes affects 170,000 people in Scotland and we are delighted that the innovative nature of this new medicine and its potential benefit to patients has been recognised by the SMC." Byetta is the first in a new class of medicines for the treatment of type 2 diabetes known as incretin mimetics. As well as the positive guidance from the SMC on the use of Byetta, there has recently been a reimbursement approval for Byetta in Sweden where the Pharmaceutical Benefits Board (LFN) concluded that Byetta should be reimbursed in the pharmaceutical benefits system for use in people with type 2 diabetes. Byetta is the first in a class of medicines for the treatment of type 2 diabetes called incretin mimetics. Byetta exhibits many of the same effects as the human incretin hormone glucagon like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain. Byetta is approved in the European Union as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate glycaemic control on maximally tolerated doses of metformin and/or a sulphonylurea, two common oral diabetes medications. Byetta provides sustained HbA1c control, low incidence of hypoglycaemia when used with metformin and progressive weight loss. In three separate insulin comparator studies, patients initiating exenatide generally lost weight while patients initiating insulin therapy generally gained weight. In addition, when compared to insulin glargine, exenatide was associated with a lower incidence of hypoglycaemia when used with metformin.

 
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