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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

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