SAN DIEGO—Going up against Sanofi blockbuster Lantus is no easy task, but that's exactly what Novo Nordisk and its long-acting insulin Tresiba have to do. Thanks to new data, though, the Danish drugmaker can safely say its newcomer poses no increased heart risks—and it has some advantages over its rival, too.
On Monday at the American Diabetes Association annual meeting, Novo unveiled a 7,637-patient study showing that high-risk Type 2 diabetes patients taking Tresiba were no more likely to suffer a major cardiovascular event—such as heart attack or stroke—than those using Lantus were.
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It’s good news for Novo, which kicked off the trial—dubbed Devote—after the FDA turned away Tresiba in early 2013. In sending Novo back to conduct a CV trial, the agency spurned the advice of an advisory panel, which had recommended a study postapproval instead of beforehand.
These days, however, it's no longer in vogue to simply prove a drug is no worse than its rival on a CV endpoint—in Novo’s case, time to first incidence of major cardiovascular event. Now, diabetes drugmakers are all about establishing superior cardiovascular outcomes and showing that their meds can cut down heart risks. Novo itself did so at last year’s ADA meeting with its Leader study, which showed its GLP-1 med Victoza slashed the combined risk of heart attack, stroke and death from cardiovascular causes by 13% in high-risk patients.
But “while the primary CV endpoint [in Devote] was not the superiority that generates a lot of the buzz like Leader, there is a considerable amount to talk about and excitement around the Devote data,” Todd Hobbs, M.D., Novo’s North American chief medical officer, said in an interview.
Case in point: Tresiba patients saw their rate of severe hypoglycemia plunge by 40%, and the med also reduced nighttime episodes of severe hypoglycemia by 53%.
These are “very important” considerations for clinicians using basal insulins, according to Hobbs.
“Especially in this population with higher CV risks, you do not want these individuals to have a severe episode, so really trying to avoid those is paramount to your insulin therapy,” he said. “Those kinds of reductions—roughly half—makes a difference.”
Next up? “Certainly we’ll talk to the FDA about what this means from a labeling perspective,” Hobbs said.
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Novo wouldn’t mind a regulatory boost for the med, which it’s counting on to do big things for its top line. Like its diabetes peers, the company has struggled under pressure from increasingly aggressive payers, and last September, that pressure helped force it to cut 1,000 jobs from its payroll.
Of course, stepped-up competition for Tresiba doesn't help, and that’s what arrived mid-December with the launch of Eli Lilly’s Lantus biosimilar, Basaglar. That med won favor from major pharmacy benefits manager CVS before hitting the market; last August, the payer announced it would sub Basaglar in for Sanofi’s moneymaker on its 2017 formulary.