Once-weekly exenatide pen gets EC nodOctober 10, 2018
The European Commission (EC) has approved Bydureon BCise (exenatide 2mg prolonged-release suspension for injection in pre-filled pen) for the treatment of patients with type-2 diabetes.
The new formulation of once-weekly Bydureon is an improved single-dose, pre-filled pen device that requires no titration and is approved for use in combination with other glucose-lowering medicines, said AstraZeneca, the maker of the device.
The EC approval is based on the data from two clinical trials, Duration-Neo-1 and Neo-2. Duration-Neo-1 is a 28-week, randomised, open-label, comparator-controlled trial (n=375), which showed that once-weekly Bydureon BCise demonstrated an HbA1c reduction of 1.4% vs. 1.0% for twice-daily Byetta (exenatide) injection at 28 weeks (baseline HbA1c 8.5% and 8.4%, respectively). Additionally, Bydureon BCise demonstrated a mean weight reduction of -1.5 Kg as monotherapy vs. -1.9 Kg (baseline was 97 Kg) when combined with certain oral antidiabetic medicines.
This new formulation of once-weekly Bydureon BCise was approved by the US FDA in October 2017.