US FDA approves AZ's Bydureon Pen as Lilly eyes GLP-1 market

By Dan Stanton

- Last updated on GMT

US FDA approves AZ's Bydureon Pen as Lilly eyes GLP-1 market

Related tags Insulin

The US FDA has approved a weekly single-use syringe for AstraZeneca’ Bydureon as Lilly reveals its ambition in the GLP-1 drug market.

The device, which delivers AstraZeneca’s Bydureon (exenatide) glucagon-like peptide-1 (GLP-1) agonist drug, was approved by the US Food and Drug Administration (FDA) on Monday as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.

“This system eliminates the need for the patient to transfer the medication between a vial and syringe during the self-injection process,”​ AstraZeneca spokesperson Vanessa Rhodes told

The manually operated, pre-filled single-use pen injector “is supplied as a pen device containing exenatide microspheres and diluent prefilled into separate chambers of the glass cartridge,” ​she continued.

“The pen is supplied with one custom needle specific to this delivery system,” ​she added. “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.”

GLP-1 Competition

Bydureon is one of two licensed GLP-1 agonists, the other being Novo Nordisk’s market leader Victoza (liraglutide). GLP-1s are used to facilitate glucose control, by helping to increase insulin secretion, suppress pancreatic release of glucagon, reduce liver fat content and reduce appetite in people with Type 2 diabetes.

Eli Lilly is looking to penetrate this market as part of its response to the “growing diabetes epidemic”​ with its dulaglutide GLP-1 it hopes to launch later this year. During a recent conference call at the Cowen and Company 34th​ Healthcare Conference (transcript here​), Lilly’s CFO Derica Rice said its drug would also be once-weekly, but with “a ready-to-use device at a much easier administration versus Bydureon,”​ and with “the efficacy of Victoza.”

When asked about Lilly’s ambition and the potential threat to Bydureon, Rhodes said AstraZeneca does not comment on competitor products.

AstraZeneca purchased Bristol-Myers Squibb’s share of Bydureon in December​ last year, as part of a $4.1bn (€3bn) deal that saw them acquire all of BMS diabetes joint assets. Bydureon was approved in January 2012 by the FDA and for the full year 2012 clocked sales of $37m, according to AstraZeneca’s annual report.

Victoza, however, reported sales in 2013 of 11.6bn Danish kroner ($2.1bn) and holds a 71% share of the GLP-1 market (up 3% on 2012), Novo Nordisk reported​.

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