Sanofi plots real-world data push as Toujeo slashes hypoglycemia risks in seniors

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Sanofi's Toujeo beat out predecessor Lantus at lowering the risk of hypoglycemia in some patients.

SAN DIEGOSanofi’s Toujeo has plenty of competition in the basal insulin market, but new real-world data shows it may outdo its peers at cutting the risk of hypoglycemia for older patients. And Sanofi's planning three real-world follow-ups, a "major shift" from its usual data approach.

A study examining an at-risk population of seniors who had switched to basal insulin found that at a 6-month follow-up, those taking Toujeo were 57% less likely to experience hypoglycemia than those who switched to competing insulinssuch as Novo Nordisk’s Tresiba and Levemir, and Toujeo’s own predecessor, Lantus—Sanofi announced on Tuesday.

A Novo Nordisk spokesman declined to comment on the Sanofi data.

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Less hypoglycemia, of course, means more savings for payers, who have squeezed diabetes drugmakers hard over the last few years to cut down on their own rising costs.

“In the past, the communication on new data … was limited to a communication to regulators‘is this drug safe and efficacious’or to physicians. This is no longer possible,” Riccardo Perfetti, Sanofi’s VP of global medical affairs for its diabetes franchise, said in an interview. “You really need to be able to communicate to other stakeholders. I would include the patients firstpatients now want to know morebut also those who have to pay for it.”

While Sanofi believes that "data provided by randomized controlled studies need to be complemented by the real experience of the physicians and patients,” Perfetti said, the company knows real-world studies have their limitations. And that’s one reason Sanofi is conducting three complementary trials with Toujeo that it’s calling “randomized, prospective, real-life clinical studies.”

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In Europe, the company’s Reach Control study is examining patients coming to insulin from oral agents, while its Regain Control trial is looking at those switching from other basal insulins. And in the U.S., Sanofi is working on Achieve Control, which will investigate patients naïve to insulin who are randomized to receive either Toujeo or a comparator. All three of those trials will collect patient feedback on hypoglycemia and treatment satisfaction, in addition to clinical data.

For Sanofi, the approach marks a “major shift” in the way the French drugmaker serves up data on its meds, Perfetti said, adding that “it will not be only a Toujeo example.”

“Anything that will come will go through this pressure test of demonstrating that the drug meets not only the regulatory challenges, but also the ones of usability. Are the patients able to use it? Are they having a better life? Is the overall cost profile sustainable?” he said. “This is a paradigm shift, it’s not an episodic event, and we’re very much engaged in this as a philosophical change.”