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.
Once-Weekly Diabetes Treatment Gets FDA OK
By Crystal Phend, Senior Staff Writer 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.
Once-Weekly Diabetes Treatment Gets FDA OK
MedPage Today Published: January 27, 2012
WASHINGTON -- The delay is over for diabetes drug Bydureon (exenatide extended-release), with FDA approval making it the first once-weekly treatment for type 2 disease.
The announcement from drugmakers Amylin and Alkermes came after years of back and forth with the agency over the new formulation of the injectable glucagon-like peptide (GLP-1) receptor agonist.
Once-weekly exenatide was originally submitted for FDA review in 2009, but questions about the manufacturing process and a possible cardiovascular side effect, prolongation of the QT interval, proved to be a stumbling block.
The FDA approval came with a stipulation requiring Risk Evaluation and Mitigation Strategy (REMS) be put in place to address concerns over acute pancreatitis and potential risk of medullary thyroid cancer.
Amylin is also being required to conduct post-marketing studies to look at these issues and the impact on cardiovascular disease.
The most common adverse effect with Bydureon was nausea, at 14% in the DURATION-5 trial. Other common effects included diarrhea, upper respiratory tract infection, and injection site nodules.
But the DURATION-5 trial showed weight loss rather than gain -- a major plus from the patient perspective -- with the once-weekly drug and no major hypoglycemic events.
That trial also showed better glycemic control with Bydureon than with the once-daily version of exenatide (Byetta).
Byetta was approved for treatment of type 2 diabetes in 2005. The weekly formulation gained European regulatory approval in mid-2011. Lilly had been a partner in development of Bydureon until late 2011.
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