The US Food and Drug Administration (FDA) has approved Amylin’s once-weekly diabetes drug Bydureon at the third time of asking.
Bydureon had twice been rejected by the FDA, with the administration seeking more data as to how the drug affects the heart despite it receiving European approval in June 2011.
Bydureon, a glucagon-like peptide-1 receptor agonist, is an extended-release formulation of Amylin’s Byetta, utilising Alkermes’ long-acting technology.
The approval does, however, come with a risk evaluation and mitigation study, noting that any benefits of the drug should be put against increased risk of acute pancreatitis and the potential risk of medullary thyroid carcinoma.
The drug will also need to meet post marketing requirements that will assess the drug’s efficacy against MTC and cardiovascular disease.
The drug’s approval also entitles Eli Lilly, the once partner of Amylin for Byetta and Bydureon, to a payment of $150m as well as royalties on sales of exenatide products.