Diabetes, Results

Novo’s big reveal: GLP-1 drug semaglutide cuts cardio risks, but just may blind you

First, the good news for Novo Nordisk’s diabetes drug semaglutide: The drug reduced the number of major cardio events by 26% among high-risk patients in a late-stage trial.

Now, the bad news: There was a significant spike in diabetic retinopathy among patients taking semaglutide — with an unexpectedly higher rate of blindness — and they also dropped out of the drug arm at a faster pace.

The big number that Novo will focus on as it preps for an expected approval: 39%, which measures a major reduction in the risk of stroke. There was also a drop in the rate of heart attacks in the drug arm, but researchers say that it wasn’t statistically significant.

Add it all up and you have a data set that Novo will take to regulators with high expectations of an approval, and a strong position to protect its big GLP-1 position in the huge diabetes market. Novo’s big drug, Victoza, has had to compete against once-weekly Trulicity, but the pharma company is coming back with a more convenient dosing of its own now.

Victoza and Jardiance, from Eli Lilly and Boehringer, have also both demonstrated reduced cardio risks. And Novo’s Mads Krogsgaard Thomsen tells Reuters that he’s planning a longer trial for semaglutide which could put it in a position to spell out the cardio advantages on the label.

The major players in the diabetes market are known for duking it out over every new R&D wrinkle to come along. (That’s one factor that provoked early skepticism for MannKind’s inhaled Afrezza, which went unpartnered until Sanofi came along — briefly — for a rocky ride into the market.) And Novo is as competitive as anyone.

Thomsen, executive vice president and chief science officer of Novo Nordisk, had this to say:

“The results of SUSTAIN 6 support the strong potential of once-weekly semaglutide in type 2 diabetes treatment and we look forward to regulatory submission later this year. The SUSTAIN 6 results further strengthen the clinical evidence for the Novo Nordisk GLP-1 receptor agonist portfolio with the finding of additional benefits beyond glycaemic control and weight loss in adults with type 2 diabetes at high cardiovascular risk.”

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RAPS Regulatory Convergence 2017