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The EC grants marketing authorisation to Byetta

The diabetes drug passes European trials, seven years after US approval.

The European Commission (EC) has granted marketing authorisation to Byetta, an injectable prescription medicine for the treatment of type II diabetes, based on a double-blind, 30-week clinical trial, said the drug-makers Amylin Pharmaceuticals and Eli Lilly and Company.

The decision was based on trials in which ten micrograms of Byetta or placebos were added to insulin glargine therapy (with or without metformin, pioglitazone or both), titrated to achieve target fasting glucose levels. At trial entry, the dosage of insulin glargine for patients at increased risk of hypoglycemia was reduced by 20 per cent.

In November 2011, Amylin and Eli Lilly announced that they had amicably terminated their ten-year collaboration. As part of the transition plan outside the US, Amylin will assume responsibility for exenatide product commercialisation efforts on a market-by-market basis by the end of 2013.

During this period, Amylin will work with Eli Lilly on plans for the markets outside the US.

Weyer added: “In a clinical trial, patients using fixed-dose Byetta with titrated basal insulin achieved better postprandial and overall glycemic control, without weight gain or an increased risk of hypoglycemia, compared to patients using titrated basal insulin without Byetta.”

Byetta was approved in the US in April 2005.