Byetta cleared for add-on therapy with basal insulin in EU

US biotech firm Amylin Pharmaceuticals (Nasdaq: AMLN) and drug major Eli Lilly (NYSE: LLY) said on Friday that the European Commission has granted marketing authorization for their Byetta (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or Actos (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.

The decision comes after a favorable assessment earlier this year of Byetta and basal insulin by the European Medicines Agency advisory panel (The Pharma Letter February 20). The US Food and Drug Administration approved the like indication last year. Last fall, Lilly and Amylin announced that they had terminated their decade-long collaboration on Byetta and the earlier diabetes treatment Bydureon (exenatide; TPL November 9, 2011). As part of the transition plan outside the USA, Amylin will assume responsibility for exenatide product commercialization efforts on a market-by-market basis by the end of 2013. Amylin paid Lilly $250 million up front for global rights to the drug, and will also be eligible to make revenue-sharing payments of $1.2 billion.

Patients in pivotal study achieved better glycemic control overall and after meals