LISBON, Portugal—Novo Nordisk’s combination med Xultophy, which marries its GLP-1 blockbuster Victoza and newest basal insulin Tresiba, became the latest diabetes med to show it could dampen risk factors for cardiovascular disease.
The analysis, unveiled Wednesday at the European Association for the Study of Diabetes meeting in Lisbon, showed Xultophy patients had significantly lower systolic blood pressure, total cholesterol and LDL, or “bad” cholesterol, compared with those treated with two different basal insulins alone.
It’s not an outcomes trial showing a direct effect on the risk of heart attacks, stroke or death, like Victoza’s Leader study—which led to a new FDA nod for the med—or follow-up med semaglutide's Sustain 6. Rather, it's a look at those known risk factors for CV disease, an important complication of diabetes.
“People with type 2 diabetes have a higher risk of a heart attack or stroke compared to the general population, so reducing this risk as much as possible should be a central goal of treatment,” Tina Vilsbøll, a professor at the Steno Diabetes Center in Copenhagen, said in a Wednesday statement.
The Danish drugmaker has doubled down on GLP-1 diabetes drugs as the insulin market has grown increasingly competitive, and Xultophy is one of the key pieces of that growth strategy. The med launched in May, and it won a spot on Express Scripts’ national formulary in August, showing that payers will cover combination drugs if diabetes drugmakers can make a case for them.
Novo has been bullish on Xultophy, of course. ”I think you can expect as much of Xultophy as of Tresiba," Novo R&D chief Mads Krogsgaard Thomsen has said. The combo product has some of the strongest late-stage data he's ever seen. "If not the strongest," he said ahead of the product’s approval.
Another key GLP-1 product for Novo is semaglutide, the weekly follow-up to Victoza that’s expecting an FDA approval decision by year’s end. An analysis released at EASD Tuesday showed semaglutide patients in the Sustain series of trials beat a variety of active comparators—including Sanofi’s basal insulin Lantus—on a composite endpoint comprising blood sugar reduction and weight loss.
Analysts have said that the market for GLP-1/insulin combo drugs could be worth $6 billion or more. Xultophy isn’t without competition in that field, however: Sanofi’s Soliqua won U.S. approval simultaneously with Xultophy and launched early this year. The Novo med is expected to hit $1.2 billion in sales by 2021, and Soliqua is pegged at up to $960 million by 2022. Analysts believe both launches will be slow, however.