Please login to the form below

Not currently logged in

AZ gets green light for Bydureon pen in US

FDA approval comes after year-long delay
AstraZeneca AZ headquarters London UK

AstraZeneca (AZ) has finally secured US approval for a pen injector version of its once-weekly diabetes drug Bydureon after a delay of more than a year.

Bydureon Pen (exenatide) had been due to reach the market at the end of 2012 or in early 2013, but was held up by an FDA request for more data. It will be launched onto the market later this year, said AZ in a statement.

The GLP-1 agonist - which is also sold in an immediate-release formulation as Byetta - is used as an adjunct to diet and exercise to improve the control of blood sugar in patients with type 2 diabetes. At the moment, Bydureon is approved in a formulation that requires the patient to transfer the medication between a vial and syringe during the self-injection process.

Exenatide is one of the basket of diabetes and metabolic disorder drugs AZ acquired from Bristol-Myers Squibb (BMS) earlier this year, and AZ has said it expects to be able to grow it into a big-selling franchise.

Byetta - which is given before meals every day and is already available as a pen injector - doubled its sales in 2013 to reach $206m, while once-weekly Bydureon grew nearly five-fold to reach $151m.

Despite the strong growth the two drugs are lagging behind the market leader in the GLP-1 agonist category, Novo Nordisk's Victoza (liraglutide), which topped $2.15bn last year. Victoza is also delivered via a pen injector and can be given once-daily, independently of mealtimes.

The complexity in delivering Bydureon - it currently requires a six-step preparation and administration process - is thought to have held back its growth in the marketplace despite the added convenience of only requiring once-weekly dosing.

The approval of the door chamber pen will be followed by the filing of an autoinjector device next year that will provide even more patient convenience, while AZ is also working on a once-monthly formulation for the drug, according to AZ's chief medical officer Briggs Morrison.

3rd March 2014

From: Sales



Featured jobs

Subscribe to our email news alerts


Add my company
OPEN Access Consulting

OPEN Access Consulting is a specialist market access agency within the OPEN Health Group. As value communications experts we specialise...

Latest intelligence

AstraZeneca’s oncology renaissance
Susan Galbraith played a key role in restoring AstraZeneca’s place in cancer drug development – she talks about the future of oncology and why there’s more to be done to...
Navigating the antibiotic resistance crisis
Blue Latitude Health speaks to Tara DeBoer, PhD, Postdoctoral Researcher and CEO of BioAmp Diagnostics to explore the antimicrobial resistance crisis, and learn how a simple tool could support physicians...
Combined immunotherapies – potential and pitfalls
‘Combining therapeutic compounds is the first logical step towards better results, namely higher rates of patients responding to treatment, with deeper and more sustained responses’...