AstraZeneca's Farxiga chops follow-up CV events by 16% in heart attack patients with diabetes

AstraZeneca is stepping up its case for its SGLT2 diabetes drug Farxiga with new numbersshowing it can cut the risk of serious cardiovascular complications in heart attack and heart failure patients.

In a new analysis of outcomes trial data, Farxiga helped reduce hospitalizations in diabetes patients with heart failure, with the biggest risk reductions among patients with reduced ejection fraction, a measure of how well the heart pumps blood. Among patients with a reduced ejection fraction, the rate of hospitalizations was 36% lower for those using Farxiga versus those taking placebo.

For patients without a reduced ejection fraction, Farxiga lowered the hospitalization rate by 24%.

And in an analysis focusing on patients who'd suffered a heart attack, Farxiga lowered the rate of a second CV event by 16%. Naeem Khan, a VP of medical affairs in cardiovascular and metabolic diseases at the company, said in an interview the reduction was "absolutely phenomenal."

The new data bolster AstraZeneca's argument for Farxiga against other SGLT2 drugs in its class, which have put up their own cardiovascular outcomes data. Two of them—Eli Lilly and Boehringer Ingelheim's Jardiance and Johnson & Johnson's Invokana—already bear labels noting their cardiovascular benefits. AZ is hoping a similar nod will come through for Farxiga late this year.

Both analyses were released Monday at the American College of Cardiology meeting in New Orleans, and were based on data drawn from Declare, an outcomes trial pitting Farxiga against placebo in more than 17,000 patents with CV risk factors or established CV disease. In the big Declare data release last November, AZ reported that Farxiga cut hospitalizations for heart failure and CV deaths by 17%. Monday's analyses are the first two from that trial.

Data from that trial formed the foundation for Farxiga's potential label update. Rod Wooten, AstraZeneca VP of Cardiovascular and Metabolic Diseases, told FiercePharma that the FDA has accepted its application for the label tweak, and AZ hopes for an approval in the fourth quarter. In the meantime, the company plans to present further subanalyes at future medical meetings, including the American Diabetes Association's annual meeting in June.

AstraZeneca has been working for several years since Farxiga's launch to build the case for the medication. The company previously 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. And last summer, AZ presented an analysis from that study showing a "significantly" lower risk of cardiovascular events for Farxiga patients compared with those on DPP4 diabetes drugs.

Despite Jardiance and Invokana's own CV label language, AstraZeneca has had success marketing its med against the competition. Farxiga sales grew 30% last year to $1.39 billion. J&J, for its part, reported that Invokana sales fell 20% to $881 million last year.

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