AstraZeneca’s Bydureon took a blow back in May when it failed to cut down cardiovascular risks in Type 2 diabetes patients. But the company is hoping a new formulation will give the medication some competitive firepower.
The British drugmaker has scored an approval for Bydureon BCise, which has shown across two clinical trials that it can both reduce HbA1c—by an average of 1.4%—and ramp up weight loss, which it did by an average 3.1 pounds.
And importantly, the tweaked formulation comes in an enhanced delivery device, too. Bydureon BCise features a continuous-release microsphere delivery system designed to provide consistent levels of the drug and, in turn, “help patients reach and maintain a steady state,” AZ said.
The company is hoping Bydureon’s new look will help it stand out from its GLP-1 peers, which make up a pretty tough market. Eli Lilly’s Trulicity, for one, has been crushing it; it’s gone on a market-share grab as of late that’s resulted in a 42% piece of the new-to-brand pie, Credit Suisse analyst Vamil Divan wrote to clients last week. And sales have jumped accordingly, with Trulicity’s Q2 haul of $480.2 million more than doubling the $201.3 million it posted in the same period last year.
Novo Nordisk’s Victoza boasts an even larger new-to-brand share with 52%, and it’s also churned out heart-helping data that in August resulted in an FDA nod for reducing the risk of heart attack, stroke and cardiovascular death. So far, it’s the only med in the class that has shown it can improve CV outcomes; Bydureon fell just short of that distinction this year, though it did prove it didn’t have any negative effects on the heart.
RELATED: Top 10 diabetes drugs by 2016 sales
And then there’s Novo’s forthcoming semaglutide, a candidate that’s primed to poach patients from its in-class rivals. The prospect last week cruised to a 16-0 approval recommendation from an FDA advisory panel.
“We believe semaglutide may be sufficiently differentiated to catalyze GLP-1 growth with rapid uptake coming from other classes, as well as share from both Victoza as well as Trulicity,” Divan said, noting that semaglutide scripts could represent a quarter of GLP-1 prescriptions within one year.
AZ, though, has faith in its long-tenured med, whose seven years’ worth of safety data the company believes will continue to work in its favor. “It’s going to be up to the physicians to determine what is appropriate care for their patients, but we think Bydureon is very good,” Jim McDermott, AstraZeneca’s Medical Affairs lead for diabetes, said last month.