Eli Lilly and partner Amylin won approval in the European Union for their new diabetes drug Byetta yesterday, and should be in a position to launch the fast-growing new product there next year.

Byetta (exenatide) is an incretin mimetic that is an add-on therapy, used in patients with type 2 diabetes whose blood glucose levels aren't controlled with oral diabetes agents such as metformin or sulfonylureas. Studies have shown that it is as effective as twice-daily insulin in these uncontrolled patients.

Byetta looks set to be a major new product for Lilly and Amylin. Total sales of the product in the third quarter were $126.4 million, a 28% increase year-on-year, despite only being launched in June 2005 and held up by manufacturing constraints that have since been resolved.

In the USA, Lilly reports as revenue its 50% share of Byetta's gross margins and its sales of Byetta pen delivery devices to Amylin Pharmaceuticals; for the third quarter, this revenue totalled $62 million, a 19% increase compared with the second quarter of 2006.

That said, Byetta’s advance could see a brake applied by the strong launch of Merck & Co’s new DPP-4 inhibitor Januvia (sitagliptin) and the upcoming introduction of Novartis’ rival compound Galvus (vildagliptin), expected in early 2007.

Data from market research company ImpactRx show that Januvia captured 14% of new prescription for diabetes drugs last week, despite only being approved in October, while Byetta captured 9% of new scrips in the same period.