NEW ORLEANS--AstraZeneca can’t tout the same cardiovascular benefits for its SGLT2 med, Farxiga, that rivals Eli Lilly and Boehringer Ingelheim can--at least, not yet. But in the meantime, it’s trumpeting positive data from a pair of analyses, one testing the med in diabetes patients with kidney problems and the other examining it in tandem with potassium-sparing diuretics.
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.
“SGLT2s diminish in terms of their ability to lower glucose as renal function decreases, so what we wanted to do was see if there were attributes or benefits besides just lowering blood glucose,” Jim McDermott, AZ’s head of U.S. medical affairs for its diabetes unit, told FiercePharma.
And it’s good news for AZ that the evidence suggests there are, considering that about 1 in 3 adults with diabetes exhibit renal impairment, lead investigator Hiddo Lambers Heerspink said in a statement.
And in addition, “excretion was actually still high” in patients with renal impairment, suggesting the potential of a renal benefit for Farxiga. “You’d have to do a renal outcomes trial” to really establish that benefit, McDermott said--something AstraZeneca is talking about launching--but the data provided a “nice signal.”
In the other analysis, Farxiga--when administered alongside a potassium-sparing diuretic--cut down A1C, body weight and blood pressure without significantly upping potassium levels, researchers found, eliminating the potential for the hyperkalemia concerns that have surrounded Johnson & Johnson rival Invokana.
The new results are important for AZ as it looks to keep pace with its SGLT2 brethren. Last year, Lilly and BI’s Jardiance made headlines when it became the first diabetes med to reduce the combined risk of heart attack, stroke and cardiovascular death among high-risk patients--and J&J and AZ won’t wrap up their cardiovascular outcomes studies until 2017 and 2019, respectively.
In the meantime, J&J, which currently boasts "formulary dominance," may be able to preserve its position by offering rebates and piggybacking off of Jardiance’s success, Bernstein analyst Tim Anderson wrote in a September note to clients. AstraZeneca, on the other hand, "to some degree … gets left out in the cold," he said.
McDermott, though, thinks it’ll be worth the wait for AZ’s CVOT data, considering that the British pharma giant’s study--DECLARE--will be the largest outcomes trial in the class, with more than 15,000 patients. And on top of that, “We’re not just looking at secondary prevention--that is, patients who already had an event, and then you’re treating them to try to prevent a second event--but we’re also looking at patients for primary prevention,” he said. It’s “going to apply more to a wider population of patients with diabetes.”
"I think that’s a huge advancement and really what the marketplace is looking for," Topher Brooke, AZ's VP of diabetes in the U.S., added. "If we continue to pursue the science, Farxiga will absolutely be competitive moving forward."
- read AZ's release
Special Report: The New Drug Approvals of 2014
Related Articles:
After FDA snub, AZ diabetes combo faces potential years-long delay
Lilly, BI step closer to a new heart-risk marketing push on Jardiance
You say you want a revolution? Lilly, BI and Jardiance may trigger one in diabetes
J&J's Invokana fends off new SGLT2 rivals to hit $278M in Q1