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ESC: AstraZeneca’s SGLT2 med Farxiga flips script on competitors with 26% CV risk cut

by Kyle Blankenship

AstraZeneca’s diabetes med Farxiga is still looking for the cardiovascular label updates its SGLT2 competitors already bear. But as of this weekend, it has new data that could help the entire class—and even pressure heart medicines outside the class, too. 

Adding Farxiga to the standard of care sliced the risk of cardiovascular death or hospitalization in heart failure patients by 26%—regardless of whether those patients had Type 2 diabetes. Those were the results from AstraZeneca’s Dapa-HF outcomes trial presented Sunday at the European Society of Cardiology Congress in Paris.

In each of its composite endpoints, Farxiga also hit its marks. The drug showed a 30% decrease in the risk of experiencing a first episode of worsening heart failure and an 18% decrease in the risk of CV death, the drugmaker said.

“We are very pleased that Farxiga was so effective in our trial—it did all the things we would like any drug to do in heart failure, which are to improve symptoms, reduce hospital admissions and increase survival,” John McMurray, of the University of Glasgow’s Cardiovascular Research Centre, said in a statement. 

For AstraZeneca, Farxiga’s latest CV turn could spell big things for the drug—as well as for its SGLT2 challengers from Eli Lilly and Boehringer Ingelheim and Johnson & Johnson.

With the new data in tow, AZ can expect a positive impact on Farxiga sales, which are on track to reach $1.6 billion globally in 2019, Wolfe Research analyst Tim Anderson said. 

Anderson opined that prescribers are likely to view Farxiga’s significant results in non-diabetic patients as a “class effect,” potentially boosting Lilly and Boehringer’s Jardiance and J&J’s Invokana, too.

“What makes this trial stand out is that results were equally impressive in both diabetics with heart failure and NON-DIABETICS with heart failure—it is the latter segment that will open up commercially both for Farxiga and other members of the SGLT2 class, like Jardiance,” Anderson wrote in a Sunday note to investors.

But could Farxiga’s win represent a loss for heart failure therapies such as Novartis’ Entresto, which recently flopped a major CV trial of its own? Possibly, according to Anderson.

On Sunday, Novartis revealed data from its phase 3 Paragon-HF trial showing Entresto didn’t hit the statistical significance threshold for reducing the combined rate of heart failure hospitalizations and cardiovascular death among heart failure patients. The drug did post a 13% decrease over standard-of-care valsartan on that metric, and researchers touted the “totality of data” showing positive biomarker improvement to soften the blow.

Still, taken together, Anderson said Farxiga may strip away some of Entresto’s heart failure patients with reduced ejection fraction (HFrEF) after its strong showing.

“DAPA-HF showed that concurrent use of Farxiga and Entresto yielded nearly the same results as using Farxiga without (Entresto),” Anderson wrote. “This would seem to suggest Entresto is at risk to losing some portion of HFrEF patients to Farxiga.”

However, presenters Sunday downplayed the competition between the two drugs, saying their different mechanisms of action still work well together, Anderson noted. If the findings do pose a negative threat to Entresto’s sales, the effects will likely be “modest,” they said.