Eli Lilly and Amylin diabetes drug gets EC approval

Eli Lilly and Amylin have announced that their Byetta (exenatide) treatment for type two diabetes has received marketing authorisation from the European Commission. Exenatide is the first example of a novel type of drug known as incretin mimetics that imitate the glucose-lowering incretin hormones that exist naturally in the human body.

It is self-administered by patients by subcutaneous injection twice a day before meals. It does not require a change in dose dependent on exercise, food intake or blood glucose levels.

EC marketing approval was based on its analysis of a number of clinical trials involving 4,000 patients that showed the safety of the drug and its efficacy in assisting patient control of blood-sugar in the long term.

Abbas Hussain, president of European operations at Lilly, said: “This approval of exenatide is a major step forward in giving health care professionals and patients in all European countries a new treatment option for the management of type two diabetes.”

He added that the needs of diabetics were not properly met by the medical industry at present and that Lilly was dedicated to the development of novel treatments for the disease.

In June, the two companies reported the results of research showing that the administering of exenatide lowered blood glucose levels in patients with type two diabetes, irrespective of the use of a thiazolidinedione or metformin.