Novo Nordisk's Tresiba snags label boost that could sharpen its safety edge

Competition in the basal insulin market has been fierce, and not only because a biosimilar version of Lantus is working to steal share. Novo Nordisk and Sanofi each have longer-acting products jockeying for sales, too.

And now, Novo’s Tresiba has just won the right to add heft to its official FDA label. The agency approved data from the Devote study on Monday showing that Tresiba reduced the risk of hypoglycemia by 40% compared with Lantus, the Sanofi insulin that long led the basal insulin field. And Tresiba will have Lantus-matching cardiovascular safety data on its label, too.

The new label won’t encompass data from two other hypoglycemia studies dubbed Switch that had been submitted with the approval app. Novo withdrew that data from consideration, the company said in a statement.

The approval comes at a time when the risks of hypoglycemia are better defined, thanks to a deeper dive into Tresiba’s Devote study, presented last fall at the European Association for the Study of Diabetes meeting.

Essentially, Type 2 diabetes patients who suffer severe hypoglycemia are four times more likely to die within 15 days, and two-and-a-half times more likely to die, period. Daily fluctuations in blood sugar were also associated with a higher risk of death.

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"Hypoglycemia is a major problem," Alan Moses, M.D., Novo SVP and chief medical officer, said when the analysis was released. "Severe hypoglycemia patients end up in the ER or in the hospital. We were gratified to see a major reduction in risk of severe hypoglycemia, both over 24 hours and more so at night.”

Primarily designed as a cardiovascular outcomes trial, Devote encompassed more than 7,600 participants, and they were at high risk of cardiovascular disease. Over the course of the event-driven study, enough patients suffered severe hypoglycemia to provide a clear picture of the death risks associated with those episodes.

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The link between hypoglycemia and death risk “may just be a marker of frailty in the population, but the association is very clear,” Moses said.

The updated label could well help Novo differentiate Tresiba from its basal insulin rivals, particularly Lantus and Basaglar, the biosimilar sold by Eli Lilly and Boehringer Ingelheim. In addition to the increase in death risks, severe hypoglycemia can lead to expensive hospital visits, something that payers would like to avoid.

And Novo needs all the help it can get these days, particularly in basal insulins, where pricing pressure has been intense. With so many competing products, payers have been pushing for larger and larger rebates—and drugmakers say they have been boosting prices to keep up, drawing at least one class action filed by patients, whose out-of-pocket costs are based on list price, not net price after rebates and discounts. An investor action was filed last year, too.

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Tresiba has racked up some significant growth—81% in 2017, to 7.3 billion kroner—but that’s still dwarfed by Novo’s older insulins, including Levemir, which brought in more than 14 billion, and Victoza, its daily GLP-1 drug, whose 2017 sales amounted to 23 billion kroner.

And Victoza itself has faced stepped-up competition from Eli Lilly’s Trulicity, a weekly GLP-1 that siphoned away market share from Victoza. Luckily, that market continued to grow overall, so the pain for Victoza hasn’t been as severe as it might have been otherwise. And Novo recently won approval for Ozempic (semaglutide), its own weekly GLP-1—and answer to direct competition from Trulicity.