Once-weekly diabetes drug wins approval on third try

Third time’s the charm for Amylin Pharmaceuticals. After two failed attempts in as many years, the San Diego-based drugmaker finally won approval today for its once-weekly diabetes medication Bydureon (exenatide).

Bydureon is a reformulation of the company’s own twice-daily injectable Byetta. Like Byetta and Novo Nordisk’s bestselling daily injectable Victoza (liraglutide), Bydureon mimics the gut hormone GLP-1 (glucagon-like peptide-1) to lower blood sugar levels. But Bydureon takes advantage of a controlled release technology developed by Alkermes, based in Cambridge, Massachusetts, to offer long-lasting diabetes care with fewer stabs of the needle and with an additional benefit over Byetta: weight loss.

That’s no small perk, notes Daniel Drucker, a diabetes researcher at Mount Sinai Hospital’s Samuel Lunenfeld Research Institute in Toronto. “This is a substantial advance for hundreds of thousands of patients who don’t like multiple injections and who are concerned struggle with weight gain on insulin therapy,” says Drucker, who led a phase 3 trial for Bydureon.

How many people currently taking daily injectables will decide to switch over to Bydureon is still unknown, but forecasts were not helped by a clinical trial reported last year showing that Bydureon was not as effective as the daily injectable Victoza at controlling blood glucose. Amylin hopes that benefits for weight and compliance will give Bydureon an edge where efficacy does not.

Bydureon may not have the weekly injectable field to itself for long, though. Indiana’s Eli Lilly and Britain’s GlaxoSmithKline both have long-acting GLP-1 analogs in phase 3 trials and Denmark’s Novo has a pair of weekly injectables in its pipeline, too.

See ‘Class of once-weekly diabetes drugs poised for approval’ from the December 2011 issue of Nature Medicine for more.

Image: Wikipedia

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