Once it wins approval, Novo Nordisk’s highly anticipated oral diabetes drug semaglutide will go up against some stiff competition. But the drugmaker just showed that its up-and-comer can take the heat.
Wednesday, the company touted positive top-line data from a pair of studies—one pitting semaglutide against Novo’s own weekly GLP-1 injectable, Victoza, and one facing it off against Merck DPP-4 giant Januvia—that Evercore ISI analyst Umer Raffat called “critical for commercial positioning.”
Against Victoza, semaglutide put up “better than expected” results on its way to demonstrating noninferiority, as Bernstein’s Wimal Kapadia wrote in a note to clients. Those included reductions to HbA1c—a key measure of blood glucose control— of 1.3% and 1.2% at 26 and 52 weeks, respectively, versus Victoza’s 1.1% and 0.9%. And in the weight-loss department, semaglutide proved superior: Semaglutide patients lost 4.7 and 5.0 kg at the same 26- and 52-week markers, compared with Victoza’s 3.2 and 3.1 kg showings.
“Novo now has an oral GLP-1 which is at least as good (if not better) than Victoza on A1C and weight loss ... but orals trump injectables—thereby making it a very compelling offering,” Raffat wrote in his own note. “From Novo’s perspective, this is likely as good an outcome as they could have hoped for,” he added.
In the Januvia head-to-head, Novo looked to simulate a real-world setting—complete with flexible dose adjustment—and semaglutide came through. In the semaglutide arm, 63% achieved target HbA1C levels of below 7% after 52 weeks of treatment, while just 28% of patients in the Januvia arm could say the same. And semaglutide put up significantly better weight-loss numbers, too, spurring a 2.9 kg reduction compared with Januvia’s 0.8 kg.
The superior showing hardly means Novo’s work is done, though.
“Commercially, it will be all about managing the dosing protocol (fasting time, quantity of water, spacing out meals/concomitant meds) just as well as Novo managed it in the trial,” Raffat wrote.
While Novo inches closer to approval with oral semaglutide, its weekly injectable version of the drug, approved as Ozempic, is working its way through launch. The way Kapadia sees it, though, oral semaglutide performed so well against Victoza that it may just end up undermining its injectable counterpart.
“If oral sema gains more market share than we model (3.1% of US volumes in 2025), it will likely largely come at the expense of Ozempic (as well all other injectable GLP1s),” he wrote.