Diabetes Drug Bydureon (extended-Release Exenatide) Gets EU Approval

Diabetes Drug Bydureon (extended-Release Exenatide) Gets EU Approval

BANGALORE (Reuters) Jun 21 – Eli Lilly and Co and Amylin Pharmaceuticals Inc said European health regulators approved their type 2 diabetes drug Bydureon (extended-release exenatide).

The drug, which is a longer-acting, once-weekly version of Lilly’s widely-used diabetes drug Byetta, has not yet been approved by U.S. regulators.

Both drugs compete with Novo Nordisk’s Victoza, which is injected daily.

Bydureon’s U.S. approval application was filed in 2009, but the regulators rejected the drug and asked for more data in late-2010.

The companies plan to submit a response in the second-half of 2011.

The European agency’s expert committee on new drugs had backed Bydureon in April.

Reuters Health Information © 2011