When Bayer unveiled early-stage results from a finerenone trial at the European Society of Cardiology Congress in 2014, the company declared it was going all in on the kidney disease drug.
Later that year, Bayer began a trio of phase 3 trials so exhaustive that data are still being released seven years later.
Fast forward to Saturday at ESC where Bayer showed off more evidence of the benefits of the drug—now dubbed Kerendia—just six weeks after its FDA approval.
While Kerendia’s efficacy figures fall short of other chronic kidney disease (CKD) treatments such as AstraZeneca’s Farxiga and Johnson & Johnson’s Invokana, Bayer believes there is a market for it as a complementary therapy because it’s in a different drug class.
“The comment that we get back constantly from the medical community is that they are grateful that they now have two treatments they can provide to patients to slow down kidney disease and prevent cardiovascular events,” Lars Schwichtenberg, Bayer’s global head of cardio renal and heart disease, said in an interview with Fierce Pharma.
In the Figaro-DKD study, focusing on patients with chronic kidney disease (CKD) and Type 2 diabetes, Kerendia demonstrated a 13% reduction in cardiovascular events over patients receiving placebo.
Additionally, in Fidelity, a prespecified exploratory meta-analysis of the Figaro-DKD and Fidelio-DKD trials, it was found that Kerendia reduced the risk of cardiovascular outcomes by 14% compared to placebo across all stages of CKD.
The Figaro and Fidelio studies included more than 13,000 patients from 48 countries. Fidelio, which provided the backing for Kerendia’s FDA nod, showed that the drug prevented kidney deterioration, and pitted against placebo, reduced renal outcomes by 18% and cardiovascular outcomes by 14%.
“We do these megatrials because they’re so important for our understanding of the science,” Amit Sharma, Bayer’s cardiovascular and renal chief in the U.S., said in the same interview. “Because we have such a large dataset, we feel very confident that this is going to translate to real-world clinical outcome benefits.”
The potential patient population is large. Among people living with Type 2 diabetes, roughly 40% will develop CKD. Of the 160 million globally with both conditions, one in five will have renal events and one in six will develop cardiovascular ones. Patients living with CKD and Type 2 diabetes are three times more likely to die from a cardiovascular event than people with Type 2 alone.
The other big brand name CKD drugs such as Farxiga, which generated $1.96 billion last year, and Invokana, which made $795 million, are in the SGLT2 class, while Kerendia is a mineralocorticoid receptor agonist (MRA). Kerendia was approved in July and launched in early August.
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Like older MRAs, such as Pfizer’s Inspra, which is used to treat high blood pressure and inflammation, there are safety concerns as they produce high potassium levels in the blood. Kerendia’s label warns of this condition, hyperkalemia.
In Figaro-DKD, in which 7,437 participants were given Kerendia once daily or placebo when added to standard of care, 10.8% of those who received Kerendia had hyperkalemia-related events as opposed to 5.3% of those on placebo. Treatment was discontinued due to the disorder in 1.2% of Kerendia patients versus .4% of those on placebo. There were no hyperkalemia deaths in either group.
However, Kerendia comes with a major safety advantage as a nonsteroidal treatment, setting it apart from the SGLT2s.
In a treatment area that has changed dramatically over the seven years of Bayer’s trial, Kerendia has sustained, proving its worth as a complementary therapy, Bayer figures.
“You’re not going to see these kind of trials in the future because they’re so expensive and there’s so much regulatory risk. So this dataset is really priceless,” Schwichtenberg said, adding that seven years of data are important.
“These hard outcomes really matter because that’s what patients really don’t want. They don’t want to die. They don’t want to have a heart attack. They don’t want to have a stroke. They don’t want to have heart failure,” he said.
