Bayer is marking its return to the U.S. cardiovascular arena with its drug finerenone to treat not just kidney disease in Type 2 diabetes patients, but also heart disease. Yet, questions still swirl over how well the company will fare against dominant therapies from AstraZeneca and Johnson & Johnson.
The FDA on Friday approved finerenone, sold as Kerendia, to reduce the risk of kidney function decline, kidney failure, cardiovascular death, nonfatal heart attacks and hospitalization for heart failure in patients with chronic kidney disease associated with Type 2 diabetes.
With the agency’s nod in hand, Kerendia will become the first nonsteroidal mineralocorticoid receptor antagonist, or MRA, approved for diabetic kidney and heart disease. It’s a win for Bayer, which is facing a patent cliff for two of its bestsellers—blood thinner Xarelto and eye drug Eylea—and is quickly trying to nail down its next potential blockbusters.
The drugmaker expects substantial growth from Kerendia as well as its prostate cancer drug Nubeqa and heart failure medicine Verquvo, CEO Werner Baumann told analysts in May.
About 40% of Type 2 diabetes patients in the U.S. will ultimately develop chronic kidney disease, Bayer figures, and many of them are at high risk of poor cardiovascular outcomes. Kerendia is designed to block the production of steroids in the body that degrade heart function and lead to kidney damage spurred by fibrosis and inflammation.
“There’s a shared recognition that kidney disease demands a kidney treatment,” Sebastian Guth, Bayer’s president of pharmaceuticals for the Americas, told Fierce Pharma. He added that the focus over the last 20 years has been largely on managing diabetes and blood pressure.
Bayer’s once-daily Kerendia will come with a price tag of $19 per day before discounts and patient assistance programs, Guth said. The company’s launch has focused on patient advocacy groups to drive awareness for the importance of early detection, he said.
“We’re ramping up commercial production as we speak and expect to have product available to physicians and patients in the U.S. by the end of July,” Guth said.
In its approval, the FDA cited Bayer's 5,600-person late-stage trial, known as FIDELIO-DKD, which found Kerendia beat placebo when it came to kidney function. That included fending off kidney failure—when patients need dialysis or a transplant to survive—death from kidney disease or slowing decline in estimated glomerular filtration rate, or the rate at which the kidneys could filter blood.
That trial found Kerendia also reduced the composite risk of time to first occurrence of cardiovascular death or nonfatal heart attack, stroke or hospitalization for heart failure over placebo. The cardiovascular measures were done through secondary endpoints in the trial, and Bayer has followed those results up with another study, known as FIGARO-DKD, which enrolled more patients and has a primary goal of measuring the drug's impact on cardiovascular issues.
Kerendia will now face off against the established SGLT2 inhibitors, AstraZeneca’s Farxiga and Johnson & Johnson’s Invokana. Bayer started Kerendia’s development before those medicines hit the market, but they have quickly taken off since.
Farxiga sales show just how dominant it has been. The drug brought in (PDF) $1.96 billion in 2020, an increase of 30% at constant exchange rates. Meanwhile, Invokana reeled in $795 million last year, up 8.2% from $735 million in 2019.
While it’s always tricky to conduct cross-trial comparisons, Kerendia’s performance did not fare as well when compared to the high bar set by the SGLT2 inhibitors, Evaluate wrote earlier this year, estimating peak sales of $533 million by 2026.
But in Bayer’s view, the company isn’t competing with the SGLT2 inhibitors, Guth said. That’s because Kerendia isn’t an antidiabetic drug and doesn’t interfere with a patient’s glycemic control.
“Kerendia is positioned to improve on the standard of care for chronic kidney disease in Type 2 diabetes as the first and only treatment of its kind proven to reduce both kidney and cardiovascular outcomes,” Guth said.
While some MRAs, such as Pfizer’s Inspra, are already used to treat high blood pressure and beat down inflammation and scarring that come with diabetic kidney disease, their use has been limited because of safety concerns.
Bayer, on the other hand, has argued that because Kerendia is nonsteroidal, it should lead to fewer side effects, including hyperkalemia, characterized by very high levels of potassium in the blood.
In Kerendia’s larger trial, adverse events occurred at similar rates between both trial arms. However, hyperkalemia was twice as frequent in the Kerendia arm over placebo. The FDA named it as a side effect in its approval and warned that patients receiving simultaneous treatment with strong CYP3A4 inhibitors or those with adrenal insufficiency shouldn't take Kerendia.
The good news for Bayer is that the hyperkalemia cases rarely led to hospitalization in the clinical trial, and there were no reported deaths, said Bayer’s Ike Ogbaa, M.D., U.S. cardio renal executive medical director. Those findings were a "credit to the drug’s clean profile," Ogbaa added.