Eli Lilly and Amylin Pharmaceuticals may put their disagreements over marketing pacts to one side for a while after regulators in Europe gave the thumbs-up to the firms' once-weekly diabetes drug Bydureon, which is also partnered with Alkermes.
The European Commission has granted marketing authorisation to Bydureon, which is a long-acting version of Lilly and Amylin's Byetta (exenatide), a twice-daily treatment. The approval covers treatment of type 2 diabetes in adults in combination with metformin, a sulfonylurea and a thiazolidinedione, as well as metformin/sulfonylurea and metformin/thiazolidinedione combos.
The European green light is principally based on data from the DURATION clinical programme in which Bydureon showed improvements in glycaemic control with just one dose per week, while most patients also lost weight. The most common side effect was mild-to-moderate nausea, which affected 20% of patients but decreased over time in most cases.
Enrique Conterno, president of Lilly Diabetes, noted that "as the global impact of diabetes continues to expand, so does the need for innovative medicines to help people living with diabetes successfully fit treatment into their lives". He added that Bydureon is "the first and only once-weekly treatment for type 2 diabetes and has demonstrated powerful efficacy in multiple clinical trials".
Refile to FDA soon
Europe's regulators have looked more kindly on Bydureon than their counterparts in the USA. The Food and Drug Administration issued a complete response letter in October 2010 and asked for more information, specifically "a thorough QT study" to look at the potential arrhythmia liability of the drug. The companies plan to submit a response in the second half of this year.
Lilly, which will market Bydureon in Europe, is currently involved in a legal spate with Amylin in the USA revolving around the former's plans to use the same sales force to sell both exenatide-based products and the Boehringer Ingelheim-developed oral dipeptidyl peptidase-4 inhibitor Tradjenta (linagliptin), a rival drug to Byetta and Bydureon.