AstraZeneca ($AZN) won U.S. approval of its Bydureon pen for once-weekly treatment of Type 2 diabetes. The pen will be the first of its kind to hit the market. The prefilled, single-use pen injector delivers microspheres that house exenatide, which is slowly released for better glycemic control.
Bydureon, which AstraZeneca picked up in its acquisition of Bristol-Myers Squibb's ($BMY) diabetes business in February--and which BMS had acquired from Amylin in August 2012--collected an earlier FDA approval as an injection. But the troubled Bydureon took a fall from projections, ranked by analysts in April 2013 as one of the top 10 blockbuster duds in biopharma.
A new delivery system for the same formulation can make a big difference, and AstraZeneca is looking to turn that flop around in the form of a pen injector that could make the drug more patient-friendly and accessible.
"The Bydureon Pen is a manually operated, prefilled single-use pen injector," AstraZeneca spokesman Andrew Davis told FierceDrugDelivery in an email. "… The pen is supplied with one custom needle … specific to this delivery system. The dose is prepared by affixing the covered needle to the pen, twisting the knob to transfer the diluent via a bypass channel to the microsphere chamber, and then agitating the mixture to suspend the microspheres."
Bydureon is designed to deliver the GLP-1 agonist exenatide, which is slowly released from small microspheres throughout the week and can be taken any time of the day with or without meals, according to the company. Using a pen instead of a self-injection can make the process much simpler.
"This system eliminates the need for the patient to transfer the medication between a vial and syringe during the self-injection process," Davis wrote.
The pen should be available to patients in the U.S. later this year, the company said.
AstraZeneca also sells an immediate-release version of the GLP-1 agonist called Byetta, which is already available in a pen injector. Between the two treatments, the British-Swedish company is looking to turn its diabetes business into a market leader, though it lags behind Novo Nordisk's ($NVO) once-daily, pen-injected Victoza, according to a PMLive story this week.
AstraZeneca is looking to improve upon the delivery concept for Bydureon, gunning for approval of an autoinjector device next year and, in the longer game, developing a once-monthly version of the drug, chief medical officer Briggs Morrison told PMLive.
"We are pleased to receive approval for the Bydureon Pen which can provide a powerful reduction in blood glucose levels along with the potential benefit of weight loss, through a once-weekly dose in a prefilled device," Morrison said in a statement.
- here's the release
- and here's the PMLive story