Eying a potential blockbuster, Bayer has been busy making the case for its new kidney disease launch Kerendia since the med won approval last summer. Now, the company is touting a pooled dataset showing a reduction in cardio and kidney events for high-risk patients.
In a dataset combining the results from two phase 3 trials comprising 13,000 patients in 48 countries, Bayer's Kerendia cut the risk of severe cardio and kidney outcomes for patients regardless of whether they had a history of cardio disease, the company said Monday at the American College of Cardiology conference in Washington, D.C. But patients with a cardio history saw even bigger reductions.
The dataset, dubbed Fidelity, examined cardiovascular and kidney outcomes in diabetic kidney disease patients, comparing outcomes for patients with and without a history of cardiovascular disease. Fidelity pooled the findings from the Fidelio study, which tested Kerendia against advanced renal disease, and the Figaro study, which focused on Kerendia’s effectiveness against chronic kidney disease.
Over a median follow-up of three years, patients with cardiovascular disease had an incident rate of 6.9 cardio events per 100 patient years versus 3.0 for those without cardiovascular disease. Kidney outcomes showed a similar incident count.
“Across the board you see that there is a numerically greater reduction and a greater impact in folks who are higher risk," Sameer Bansilal, Bayer’s cardiovascular medical affairs chief in the U.S., said in an interview. “I wouldn’t say it’s a surprise. I’d say it’s an intriguing hypothesis with some biological plausibility and so we’ll go to the next chapter of data generation for finerenone and look to exploit that.”
Approved last July for those with chronic kidney disease associated with type 2 diabetes, Kerendia (finerenone) is the first nonsteroidal mineralocorticoid receptor antagonist (MRA) approved for the disorder. Kerendia blocks the production of steroids in the body that degrade heart function and lead to kidney damage spurred by fibrosis and inflammation.
While Kerendia is seen as a rival to SGLT2 kidney disease treatments such as Johnson & Johnson’s Invokana and AstraZeneca’s Farxiga, data from Figaro showed it can be effective as a combo treatment with the SGLT2s, adding heart and kidney benefits.
Bayer has placed a €1 billion peak sales projection on the med. It's one launch the company is counting on to help offset future generic competition to blockbusters Eylea and Xarelto.
The drugmaker also hopes to expand its use into nondiabetic patients. In 2020, Bayer launched a phase 3 trial of Kerendia in patients with heart failure with preserved ejection fraction.
Bayer reports positive results for asundexian
In another presentation during the ACC, Bayer said on Sunday that a clinical study showed that its thrombosis prevention drug asundexian, which is in phase 2 testing as an anticoagulant, can reduce bleeding by 67% in patients with atrial fibrillation who are at risk of a stroke.
In February the FDA granted fast-track status to the drug, which is competing to reach the market against a rival Factor Xia inhibitor drug from Johnson & Johnson and Bristol Myers Squibb.
Bayer also is in a race with itself as its anticoagulant Xarelto is approaching the end of its patent life in 2026. Xarelto is one of several novel oral anticoagulants (NOACs) on the market.
“There are a significant number of people who do not get on these drugs because of the fear associated with bleeding,” Bansilal said. “We think of asundexian as a smart coagulation moderator. It will reduce thrombotic events without causing additional bleeding.”