As it approaches the end of a distinguished run, AstraZeneca’s type 2 diabetes franchise is showing its age. Sales are in decline for Byetta and Bydureon as they’ve been squeezed by formidable foes in Eli Lilly and Boehringer Ingelheim’s Trulicity, Merck’s Januvia and Novo Nordisk’s duo of Victoza and Ozempic.
But the franchise has a knack for getting to the finish line first. In 2005, Byetta was the first GLP-1 receptor agonist to hit the market. And 16 years later, the extended-release version of the drug, Bydureon BCise, has become the first once-a-week GLP-1 med to complete a trial in children and adolescents with type 2 diabetes.
During the opening day of the American Diabetes Association’s 81st Scientific Sessions, AstraZeneca presented strong phase 3 results that the company hopes will pave the way for an FDA approval by the end of this year.
“We’re excited about this data,” Jim Ruggles, the company’s U.S. medical lead for Bydureon, said in an interview. “We hope that, knock on wood, pending approval, this will provide a much-needed treatment option for this underserved patient population.”
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Many consider type 2 diabetes an adult malady. But there is an expanding younger patient population with the disease. Bydureon’s trial showed it can make a difference as it reduced A1C levels over a span of 24 weeks.
Measuring A1C, or the amount of glucose in the blood, is the primary way doctors diagnose type 2 diabetes. Those with a figure of 6.5% and higher have the disease. In the trial, Bydureon recipients came out of the study with an average A1C score that was 0.85% better than those on placebo.
In the trial, those who received Bydureon had a 0.36% reduction in A1C, while those who were given placebo had a 0.49% increase.
“That’s a major difference,” Ruggles said. “These patients were still being treated with metformin and insulin, so this speaks to the aggressive nature of this disease in this patient population.”
There was a small difference in body weight change, with the Bydureon group dropping an average of 0.59 kilograms (1.3 pounds), compared to the placebo group which gained an average of 0.63 kilograms (1.4 pounds).
When Byetta’s original manufacturer, Amylin, brought the drug to the market in 2005, doctors were excited about the benefits offered by the first GLP-1 receptor agonist. But the med has since undergone two changes in management and three in how it is delivered.
Under the commercial name of Byetta, the medicine was initially a twice-a-day treatment. When Bydureon launched in 2012, it broke ground as a once-weekly therapy. But the formulation, which required users to mix ingredients and assemble the syringe, wasn’t “user friendly,” Ruggles said.
Later, under AstraZeneca, Bydureon became available in a pen form which is no longer available. A more convenient auto-injector device now delivers the drug.
With completion of the recent trial, Bydureon may get a new last life, with a ready market.
