- British pharma AstraZeneca on Monday released top-line data from a large heart study of its diabetes drug Farxiga, delivering results that succeeded on one measure while falling short on another.
- The SGLT2 inhibitor significantly reduced a composite of hospitalization for heart failure or cardiovascular death, one of the study's two primary goals. Treatment with Farxiga did not, however, lead to a statistically significant lowering in the risk of major adverse cardiovascular events (MACE) like heart attack or stroke.
- The late-stage trial tracked more than 17,000 adults across 33 countries for as long as five years. Participants had type 2 diabetes with multiple heart risk factors. AstraZeneca called it the broadest cardiovascular outcomes study to date for an SGLT2 inhibitor.
It's mixed data for Farxiga (dapagliflozin), results which may modestly help it compete in a drug class now led by Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin).
Currently on market as a once-daily SGLT2 inhibitor, Farxiga is indicated as both a monotherapy and as a combination therapy to improve glycemic control.
As one would expect, AstraZeneca focused on the positive takeaway from the major study, singling out the significant benefit on the composite endpoint of hospitalization for heart failure or cardiovascular death.
"The results from this landmark trial are especially important since heart failure is an early and frequent complication of diabetes and associated with hospitalizations that result in a considerable societal and economic burden," Elisabeth Björk, AstraZeneca's head of the late phase cardiovascular and metabolic development unit, said in a statement.
But failing to hit on a significant risk reduction in MACE could leave Farxiga without an edge over Jardiance. J&J's Invokana (canagliflozin), which last year showed a benefit on another heart endpoint, is further competition.
Through the week ending Sept. 14, Jardiance held a more than 40% share of the SGLT2 market, according to prescription data from Iqvia cited by Cowen. Farxiga and Invokana checked in at 29% and 27%, respectively.
Jardiance set the bar for the class with its EMPA-REG outcomes study, winning an additional approval in the U.S. two years ago for reducing the risk of cardiovascular death in adults with type 2 diabetes. Neither Farxiga nor Invokana currently hold such an indication.
Specific data have not yet been released from AstraZeneca's study, leaving the magnitude of benefit unclear. The pharma said it will present trial results at the American Heart Association's Nov. 10 annual meeting in Chicago.
J&J, meanwhile, is awaiting an FDA decision on its supplemental New Drug Application for reducing the risk of MACE.
In 2017, Jardiance earned Lilly $448 million in revenue, more than doubling from the prior year. (Boehringer, which shares an unspecified share of Jardiance's gross margin with Lilly, reported over $1 billion in net sales.)
Sales of J&J Invokana, on the other hand, dipped 21% to $1.1 billion, while Farxiga revenues rose nearly 30% from the year before to just under $1.1 billion.
The SGLT2 class as a whole received bad news from the FDA on Aug. 29, when the U.S. regulator warned that a rare but potentially fatal genital disease called Fournier's gangrene may be linked to the drugs. The FDA identified 12 such cases from March 2013 to May 2018 with one patient ultimately dying.