AstraZeneca already leads the global market share race for SGLT2 diabetes drugs with Farxiga despite the fact that its competitors boast FDA labels showing heart benefits. Now, the company has data of its own to demonstrate how Farxiga can lower CV risks for patients with diabetes.
At the American Heart Association (AHA) conference in Chicago this weekend, AstraZeneca reported that Farxiga cut hospitalizations for heart failure or CV deaths by 17% over placebo. The study, Declare, tested the AZ drug against placebo in 17,000 adults with Type 2 diabetes with CV risk factors or established CV disease.
The results follow AZ’s September disclosure that Farxiga met one of two co-primary endpoints in the trial. The drug also reduced major adverse cardio events, but that difference didn’t reach statistical significance, AZ said.
In an interview, AstraZeneca’s U.S. and North America executive vice president Ruud Dobber said the reduction in hospitalizations for heart failure and CV deaths is important because heart failure is a “massive burden” for diabetes patients. Looking forward, the company will file its data with the FDA early next year in hopes of winning a CV nod for Farxiga's label.
“We think we are in a unique position to further anchor Farxiga in this very important class of medicine," Dobber said.
The Declare data reveal comes after both of Farxiga’s main rivals—Eli Lilly and Boehringer Ingelheim's Jardiance and Johnson & Johnson's Invokana—showed they could improve cardiovascular outcomes for diabetes patients. And thanks to an approval last week for Invokana, both drugs now boast FDA labels detailing their respective heart benefits.
But Dobber is confident in his company’s drug against the competition. The AZ executive said payers are excited about the results because “every hospitalization we can prevent will lead to a very substantial reduction in costs.” The company is also looking at Farxiga's effect in nondiabetic patients and in patients with chronic kidney disease.
“To put a long story short, we really believe that with this profile, we are even more competitive” in the SGLT2 class, Dobber said. AZ already leads the class globally in market share after its 2014 launch, holding 40% of the SGLT2 market.
In Invokana's outcomes trial, the drug reduced the combined risk of heart attack, stroke and CV death by 14%, a number that matched the composite reduction Jardiance posted in its own outcomes trial. Jardiance, which is now approved to reduce the risk of CV death, didn’t make much of a dent in heart attack or stroke, however; Inovkana cut those risks by 15% and 10%, respectively.
AstraZeneca has been working for several years since Farxiga's launch to build the case for the medication. 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. This 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.
Farxiga has generated $994 million in the first nine months of 2018, while J&J’s Invokana generated $653 million. In the first half, Boehringer Ingelheim reported €664 million in Jardiance sales. Boehringer and Lilly market Jardiance together under a global partnership.