With its two biggest rivals already wielding heart-helping results for the SGLT2 diabetes drugs, AstraZeneca has long been anticipating outcomes study results for its own Farxiga. And on Monday, the company reported that its contender had bested placebo at reducing hospitalizations for heart failure or CV deaths. With the result, the AZ will push for a new label as it works to grow its share in a competitive market.
The study, Declare, tested Farxiga versus placebo in 17,000 adults with Type 2 diabetes with CV risk factors or established CV disease. In addition to Farxiga's ability to cut hospitalizations for heart failure or CV deaths, investigators also saw few major adverse cardio events for patients on the SGLT2 diabetes drug. That difference didn’t reach statistical significance, however.
In an interview, Jim McDermott, AstraZeneca's VP of medical affairs for diabetes, called the findings “very significant” both from a patient and societal perspective. The company is “very pleased” with the safety profile seen in the study, too.
AstraZeneca will present the full results from the Declare study in November at the American Heart Association’s meeting in Chicago.
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Farxiga’s cardio outcomes data should give the drug a boost in a crowded field. Both of of its main rivals—Eli Lilly and Boehringer Ingelheim's Jardiance and Johnson & Johnson's Invokana—have already shown they can improve cardiovascular outcomes for diabetes patients. Only Jardiance, though, so far has the right to tout its CV results: It carries an FDA label for its ability to lower the risk of cardiovascular death.
AstraZeneca has been working to build its case for Farxiga for several years. Last year, the company presented data showing the SGLT2 drug class cut heart failure hospitalization rates by 39% and reduced deaths from any cause by 51% compared with other types of diabetes treatments.
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More recently, the company this summer presented an analysis from that study showing a "significantly" lower risk of cardiovascular events for Farxiga patients compared with those on DPP4 diabetes drugs, a class that includes Merck's Januvia and AstraZeneca's own Onglyza. At the time, McDermott said the findings boosted his confidence for the Declare readout.
Farxiga generated $639 million in sales in the first half of the year, up 36% over the same period last year.