Generic name: semaglutide
Company: Novo Nordisk
2022 sales estimate: $2.2 billion
Novo Nordisk is hoping that its new weekly GLP-1 diabetes drug semaglutide can grab the blockbuster baton from daily-dosed predecessor Victoza—and it's counting on outcomes data to help make that happen.
Submitted in December to the FDA for approval, semaglutide will have to face a range of other GLP-1 drugs, including Eli Lilly's weekly Trulicity, which has been grabbing share since its launch last year. With payers putting pressure on diabetes drugmakers for rebates and discounts, Novo knows that it will need to make a strong case for semaglutide in the crowded GLP-1 class, so it's planning to expand its outcomes research and build on its list of head-to-head studies to do just that.
In clinical trials, the Novo candidate has already knocked aside a couple of major players in the diabetes space. At the American Diabetes Association’s annual meeting last June, Novo fleshed out two studies that showed that the med was superior to AstraZeneca’s weekly GLP-1, Bydureon, as well as Merck DPP-4 stalwart Januvia. Semaglutide bested Sanofi's basal insulin Lantus in a trial as well.
Plus, semaglutide has shown it can cut overall cardiovascular risks. The weekly med cut the combined risk of heart attack, stroke, and cardiovascular death by 26% in a study called Sustain 6 presented last September. Only two other diabetes drugs have racked up data showing cardiovascular benefits, Victoza itself, and Eli Lilly and Boehringer Ingelheim's SGLT2 drug Jardiance.
“[T]he cardiovascular outcomes trial data is very unique,” Novo CMO Todd Hobbs said in an interview last year, when asked how semaglutide could hope to compete in the increasingly crowded GLP-1 field, not only with doctors and patients, but cost-conscious payers as well. “Semaglutide would be the fourth weekly to market, but the data we’ve seen so far against the weekly competitors is really strong, and we will go to payers with that.”
Novo is planning to launch a follow-up outcomes trial to add to semaglutide's CV case as soon as the drug is approved. And it's recruiting patients for a head-to-head study pitting semaglutide against Jardiance, with HbA1c levels as the primary endpoint, and body weight and hypoglycemic events among a list of secondary endpoints.
Meanwhile, Novo is also developing an oral form of semaglutide, which would be a first in that class. The company recently said it was adding a couple of head-to-head studies to that formula's development program, too, one against Victoza and one against Jardiance.