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

By Dan Stanton , 05-Mar-2014
Last updated on 05-Mar-2014 at 17:04 GMT

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

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 in-Pharmatechnologist.com.

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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