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Lilly/Amylin’s Byetta receives EC approval for use with basal insulin

Provides new option for type 2 diabetes patients unable to achieve glycaemic control

Eli Lilly & Company's type 2 diabetes treatment Byetta (exenatide) has received European approval for use as additional therapy to basal insulin.

Previously, the drug had only been approved as an adjunct therapy with non-insulin diabetes drugs, such as metformin, sulphonylureas and thiazolidinediones.

The new ruling means Byetta can now be used, with or without metformin and/or Actos (pioglitazone), as an adjunctive therapy to basal insulin for the treatment of type 2 diabetes in adults who have not achieved adequate glycaemic control.

Lilly is unlikely to see the full benefit of the approval though, with European rights of Byetta expected to be transferred to Amylin by the end of 2013.

The two companies had co-developed the drug, although Amylin decided to end their decade-long partnership in November, 2012, following the launch of Lilly's collaboration with Boehringer Ingelheim for type 2 diabetes drugs.

Amylin will also regain full rights to Bydureon, a once-weekly version of Byetta.

Amylin's senior VP, R&D Dr Christian Weyer, said: "The marketing authorisation for the use of Byetta with basal insulin provides a new option for the many patients with type 2 diabetes who are not achieving treatment goals."

The approval follows a phase III trial that compared Byetta's use as an adjunct therapy compared to placebo in people with type 2 diabetes.

Byetta was able to demonstrate a statistically significant reduction in average blood sugar levels over three months, as well as a decrease in weight.

Weyer said this was “without... an increased risk of hypoglycaemia, compared to patients using titrated basal insulin without Byetta".

26th March 2012

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