With new FDA submission, Novo Nordisk aims to trumpet Tresiba's hypoglycemia edge

Novo Nordisk just took another step toward a potential kick-start for its newest basal insulin, Tresiba. The Danish drugmaker submitted data from its cardiovascular safety study, Devote, to the FDA, hoping to amp up its label to compete in a hotly contested segment of the diabetes market.

“Potential” is a key word, however, because it depends on a., the FDA approving that new labeling, preferably with the word “superiority” attached, and b., persuading doctors and payers that comparable cardiovascular safety and a lower risk of hypoglycemia are enough to make Tresiba a favored product.

For diabetics on insulin, hypoglycemia is a much-feared side effect, particularly at night when symptoms may go unnoticed and blood sugar levels could fall dangerously low. Worried about hypoglycemia, patients sometimes skimp on insulin.

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Novo says the Devote study, a head-to-head against Sanofi’s long-dominant basal insulin Lantus, showed 27% fewer Tresiba patients suffered severe hypoglycemia compared with patients in the Lantus group. Tresiba also cut the relative risk of severe hypoglycemia at night by 54%, the company said.

"The risk of severe hypoglycemia is a major cause for people with type 2 diabetes not reaching their treatment targets," Mads Krogsgaard Thomsen, Novo’s R&D chief, said in a statement. "However, with the Devote data, we have demonstrated that the strong clinical profile of Tresiba leads to a significant reduction in severe hypoglycemia in people with type 2 diabetes."

Tresiba was pegged as a major sales driver when it was making its way through the FDA—but that was before the agency, spooked by the controversy over GlaxoSmithKline’s Avandia safety, sent the Danish drugmaker back to conduct a heart-safety study.

When Tresiba rolled out three years later, it entered a very different market: Payers had started to clamp down severely on ever-increasing insulin prices, pitting drugmakers against each other to win bigger rebates and giving exclusive formulary access in exchange.

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Plus, Sanofi had launched its newer basal insulin, Toujeo, and biosimilar competition to Lantus was looming. Sanofi was working hard to convert Lantus patients to its newer therapy ahead of that rival, which raised the stakes further.

Through it all, however, Novo has maintained that Tresiba is the superior product, and that doctors, patients and payers would come to agree. As selling points, the company points out that it lasts 42 hours and has a profile that allows patients to dose at any time of day. Now Novo has more data about its superiority to Lantus in preventing episodes of low blood sugar.

A lower risk of hypoglycemia was part of its case—and when the company rolled out Devote last year, it appeared ready to take advantage of that, touting the hypoglycemia results in its announcement of that data. Hypoglycemia risk was a secondary endpoint in the CV safety study.

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Whether Novo could parlay an updated label into a bigger share of the basal insulin market remains to be seen. Payers could well be the biggest hurdle, given their willingness to twist arms, especially in diabetes.

Meanwhile, Novo faces other troubles in the insulin market. Along with its fellow diabetes drugmakers, Eli Lilly and Sanofi, it’s facing lawsuits and investigations over insulin price increases over the last several years

Last year, Novo pledged to limit its price hikes to 9.9% and work to make its meds affordable; earlier this month, the company, along with a range of other Big Pharmas, said they’d teamed up with Express Scripts to offer certain meds to cash-paying and uninsured patients at discounted prices.