Diabetes Drug Bydureon Wins FDA Approval
Feb 01, 2012
By joe , pharmaceutical-technology.com
Tag: diabetes drug,Amylin
Amylin's Bydureon diabetes drug has won approval from US regulators.
The US FDA approved Amylin's once-weekly diabetes drug Bydureon late Friday.
Bydureon, a glucagon-like peptide-1 receptor agonist, is an extended-release formulation of Amylin's Byetta, utilising Alkermes' long-acting technology.
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.
The FDA 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.
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