AstraZeneca's diabetes med Farxiga stormed the heart failure market with a first-in-class approval last year—and in chronic kidney disease (CKD), it just left would-be rival Jardiance in the dust.
The FDA late Friday approved Farxiga, also known as dapagliflozin, to treat CKD even in patients without diabetes.
With that CKD approval in hand, Farxiga has cemented its lead against Eli Lilly and Boehringer Ingelheim’s SGLT2 rival Jardiance, which isn't expecting data from its kidney disease outcomes trial until 2022.
Meanwhile, AZ’s drug will contend—at least in part—with Johnson & Johnson’s own SGLT2 challenger, Invokana, which boasts an approval in diabetic kidney disease but not in kidney disease patients without diabetes.
Back in August, when AZ revealed detailed results from the pivotal Dapa-CKD phase 3 trial, a company exec said the data had the potential to “rewrite” medical textbooks, and AZ leadership remains abuzz with news of the approval. Mene Pangalos, executive vice president of biopharmaceuticals R&D at the British pharma, on Friday called the green light “the most significant” advancement in CKD treatment in more than 20 years.
“We are extremely excited and proud that Farxiga is now the only SGLT approved for patients with chronic kidney disease at risk of progression with or without type 2 diabetes,” Kiersten Combs, vice president of cardiovascular and metabolic disease at AstraZeneca, added in a recent interview.
The approval opens up a massive market, too: Some 37 million people in the U.S. suffer from CKD, of which only around 10% have likely received a diagnosis, Combs said.
"Chronic kidney disease for the most part is an asymptomatic disease until it progresses to quite a severe state," she said. If your kidneys are declining, "...a doctor may not actually diagnose it until very late in the disease progression."
But with Farxiga now available for CKD patients, and AstraZeneca rolling out patient and physician education programs to get the word out, the drug has the potential to allow physicians to "diagnose and intervene earlier in the disease progression," Combs said.
The FDA granted its Friday approval on the strength of Dapa-CKD. The trial enrolled 4,304 kidney disease patients with stages 2-4 disease and high levels of albumin in their urine.
In that study, Farxiga plus standard of care slashed the combined risk of worsening kidney function or death from cardiovascular or kidney problems by 39% compared with placebo. The drug also slashed mortality risk from any cause by 31%.
Meanwhile, exploratory analyses of AZ’s Declare-Timi 58 trial, which assessed the drug’s cardiovascular effects, showed Farxiga was likely to work well in patients with less advanced CKD, the company said in a release.
Under the new approval, Farxiga can be used to reduce the risk of declining kidney function, kidney failure, cardiovascular death and hospitalization for heart failure in adults with CKD.
The green light was to be expected: In early January, the FDA awarded a priority review to Farxiga’s application in CKD, teeing up a second-quarter decision.
Originally approved to control blood sugar in patients with Type 2 diabetes, Farxiga has developed an impressive reach over the last year. In early May, the drug scored a class-first nod to reduce the risk of major cardiovascular events in patients with heart failure regardless of whether they have diabetes.
That "breadth and depth" will be key to Farxiga's edge over other SGLT2 rivals in the field, Combs said.
And Farxiga sales show just how successful it's been on the market. The drug brought in $1.96 billion in 2020, an increase of 30% at constant exchange rates. It shows no signs of slowing down, either. In the first quarter, Farxiga sales skyrocketed (PDF) 50% to $625 million.
By contrast, J&J’s Invokana reeled in $795 million last year, up 8.2% from the $735 million it put up in 2019. The drug generated $150 million worldwide in the first three months of 2021, the company said in its first-quarter earnings statement.
Farxiga is available now for CKD patients, Combs said. To spread the word, AZ is "actively mobilizing" all of its customer-facing teams across both its commercial and medical organization. "[W]e believe education in this state is really important to increase diagnosis ... and treatment," she said.
Meanwhile, the company will also leverage digital marketing to seek out doctors and patients online. AZ plans to roll out an educational programs to healthcare professionals "over the next few weeks," as well as an online patient education plan that should go up in the "next few months."
Making sure CKD patients can obtain the drug is another important piece of the puzzle, and to that end, Combs says AZ has established "very broad access" to Farxiga both commercially and in the Medicare space.
Editor's note: This story was updated with additional comments from Kiersten Combs, VP, cardiovascular and metabolic disease at AstraZeneca.