Not to be left behind in the SGLT2 race, AZ launches heart, kidney failure outcomes studies for Farxiga

AstraZeneca doesn’t yet have the outcomes data for Farxiga that rivals Boehringer Ingelheim and Eli Lilly have for rival Jardiance, which show that their med helps cut the combined risk of heart attack, stroke and CV death in high-risk Type 2 diabetes patients. But AstraZeneca isn’t waiting around before it starts scouting other benefits, too.

The British drugmaker announced on Monday that it would launch two Phase IIIb studies of its SGLT2 diabetes med to “help … define the potential role” of the product in managing chronic kidney disease and chronic heart failure.

AstraZeneca’s study won’t be the first to look at an SGLT2 contender in heart failure; after last year posting a 38% reduction in the risk of cardiovascular death with Jardiance, Lilly and BI announced in April that they’d be embarking on two heart-failure specific outcomes studies that could eventually help them tap a 38 million-strong worldwide patient pool.

And while AstraZeneca won’t have any heart-helping outcomes data to match Jardiance’s until 2019, it’s hoping to see a classwide effect--meaning that whatever the Lilly and BI med can do, Farxiga can do, too. And it doesn’t want Jardiance to run away with the market in the meantime.

When it comes to kidney disease, Jardiance has already put up some strong results there, too. As its makers said in June at the American Diabetes Association’s annual meeting, data from their original outcomes trial showed that the med cut the risk for new-onset or worsening kidney disease by 39% compared with placebo, when added to standard-of-care treatment for adults with Type 2 diabetes and established cardiovascular disease.

AZ, though, will be the first SGLT2 manufacturer to start up a major outcomes trial in chronic kidney disease, “for which there are currently few treatment options and a significant unmet medical need,” the pharma giant noted in a statement.

And AstraZeneca had some positive kidney data of its own to share at the ADA meeting, giving it hope that Farxiga could come up big.

In one analysis, researchers found that Farxiga recorded a decrease in body weight and blood pressure among patients with kidney problems, similar to the decreases it posted among those with mild renal impairment or normal kidney function.

On top of that, “excretion was actually still high” in patients with renal impairment, suggesting the potential of a renal benefit for the therapy. Those data provided a “nice signal,” Jim McDermott, AZ’s head of U.S. medical affairs for its diabetes unit, told FiercePharma at the time.

- read AZ's release

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