Company: Novo Nordisk
2016 U.S. sales: $2.10 billion
Drug class: GLP-1
As Sanofi’s Lantus has led the basal insulin field and Merck’s Januvia, the DPP-4 class, Novo Nordisk’s Victoza has been the dominant GLP-1 drug for years. Lately, however, its market share is on the wane thanks to new rivals, particularly Eli Lilly’s Trulicity, which comes in 10th on this list.
Luckily for Novo, however, the GLP-1 field has grown at a fast-enough clip to keep Victoza’s sales on the rise even as its market share shrinks—just as Novo and Lilly both predicted before Trulicity’s launch. Victoza brought in $2.98 billion worldwide last year, $2.1 billion of that in the U.S. And Novo now has U.S. approval for a combination med, Xultophy, that marries Victoza with its newer basal insulin Tresiba.
As of last June, Victoza also has some cardiovascular outcomes data to its credit, showing that it cut the composite risk of heart attack, stroke, and cardiovascular death by 13%, and CV death itself by 22%. If Novo gets its way, U.S. regulators will give Victoza a risk-reduction green light later this year. That reduction in cardiovascular risks is something that two of its GLP-1 competitors, Sanofi’s Lyxumia and AstraZeneca’s Byetta, have failed to prove, at least so far.
Victoza’s patent doesn’t expire until 2023 in the U.S., Novo says, though Teva Pharmaceutical Industries filed its generic version for approval at the FDA in February. But semaglutide, a longer-acting follow-up, is at the FDA for review, with a decision date later this year. Dosed weekly, rather than daily as Victoza is, semaglutide would compete on a more even footing with Trulicity, which also follows a weekly schedule.
In clinical trials, semaglutide has not only beat its Novo predecessor, but Merck’s Januvia and AstraZeneca’s weekly GLP-1 Bydureon. And semaglutide has put up some solid CV outcomes data of its own, with a smaller trial showing risk reductions even better than Victoza’s. The company plans a larger, follow-up outcomes trial as soon as the med wins U.S. approval. It’s also recruiting for a head-to-head study against Eli Lilly and Boehringer Ingelheim’s Jardiance, which boasts an FDA approval for a CV risk-reduction indication.