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Amylin/Eli Lilly/Alkermes' Bydureon Gains Approval in Europe



In late June, the European Medicines Agency (EMA) approved Amylin/Eli Lilly/Alkermes’ once-weekly injectable drug Bydureon for type 2 diabetes. We’ve been waiting for Bydureon to be approved for quite some time, and we’re very happy that people in Europe will soon have it as an option. As background, Bydureon belongs to the GLP-1 agonist drug class, which also includes Novo Nordisk’s Victoza and Amylin/Eli Lilly’s Byetta. As the first once-weekly GLP-1 agonist, Bydureon needs to be taken much less frequently and is accompanied by less nausea than Byetta or Victoza. Because of these advantages, Bydureon could potentially help people adhere to the drug better – a major benefit in our view, given that many people have difficulties taking their medications on a regular basis.

Amylin and Eli Lilly plan to launch Bydureon in Europe in the next few months. Since the development of a pen for the drug has not yet finished (it is expected to complete in late 2012 or early 2013), the companies will be introducing Bydureon with a “custom dosing kit”, which helps patients take the drug with a syringe and vial. Bydureon comes as a powder that needs mixing with a special fluid before injecting (a bit like glucagon). When we had the opportunity to preview the custom dosing kit last year, we counted approximately 15 steps in the process, which took a total of roughly one minute to dose. While this may sound like a lot, it actually seemed pretty easy overall, especially compared to insulin because the dose of the drug is fixed.

As a reminder, Amylin, Eli Lilly, and Alkermes intend to resubmit Bydureon to the FDA by the end of the year, placing potential approval in the US in the first half of 2012. On the more distant horizon, the companies even have a once-monthly GLP-1 agonist in development! --VW

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