Bydureon succeeds in FDA-mandated trial, but market uptake could prove tougher challenge
This article was originally published in Scrip
Bydureon, the once-weekly antidiabetic exenatide, has overcome another obstacle to FDA approval. Developers Amylin, Eli Lilly and Alkermes have revealed that supratherapeutic doses of the compound do not cause a change in heart rhythm by affecting the QT interval.
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The decision by Amylin and Lilly to end their co-development and marketing deal covering exenatide antidiabetic products potentially opens the door to other partners that might be more committed to driving ex-US sales. The divorce was prompted by Lilly's recent link up with Boehringer Ingelheim for a competing product.
In September 2011 Boehringer Ingelheim and Eli Lilly announced a delay to the German launch of their novel DPP-IV inhibitor Tradjenta (linagliptin; sold in the EU as Trajenta) because of the anticipated difficulty in agreeing a suitable price with the German regulators. In Germany, most of the cost of care for most of the population is covered by a range of sickness funds funded by statutory health insurance. Furthermore, a state body - IQWiG (the Institute for Quality and Efficiency in Health Care) - is involved in setting reimbursement pricing for new medications.