US clears Bayer's Kerendia for CKD associated with type 2 diabetes

The FDA announced Friday that it approved Bayer's oral, non-steroidal mineralocorticoid receptor (MR) antagonist Kerendia (finerenone) to lower the risk of kidney function decline, kidney failure, cardiovascular (CV) death, non-fatal heart attacks, and hospitalisation for heart failure in adults with chronic kidney disease (CKD) associated with type 2 diabetes. "By blocking MR overactivation, a key driver of CKD progression, Kerendia works on a pathway largely unaddressed by existing treatments for CKD in type 2 diabetes," Bayer noted.

The filing, granted a priority review earlier this year, was supported by data from the Phase III FIDELIO-DKD trial, which compared the addition of Kerendia or placebo to standard care in around 5700 CKD patients with type 2 diabetes. Results showed that significantly fewer patients in the Kerendia group progressed to a composite endpoint that included a minimum 40% reduction in kidney function, onset of kidney failure, or kidney death.

Michael Devoy, head of medical affairs and pharmacovigilance at Bayer's pharmaceuticals unit, noted that FIDELIO-DKD "is the first large contemporary positive outcomes study in patients with CKD and type 2 diabetes with a primary composite endpoint consisting exclusively of kidney-specific outcomes." The treatment also significantly cut the risk of a key secondary goal, which assessed a composite of CV death, non-fatal heart attack, non-fatal stroke or hospitalisation for heart failure.

Decision pending in Europe, China

Kerendia, formerly BAY 94-8862, is currently under review in the EU and China, as well as multiple other countries for patients with CKD and type 2 diabetes. In May, Bayer also reported results from the Phase III FIGARO-DKD study showing Kerendia led to a significant reduction on the primary composite endpoint of CV death or non-fatal CV events compared to placebo (see ViewPoints: Another preliminary point for finerenone).

Meanwhile, the FDA expanded the label for AstraZeneca's Farxiga (dapagliflozin) earlier this year, making it the first SGLT2 inhibitor approved to treat CKD patients. That decision was based on data from the Phase III DAPA-CKD study, which showed that adding Farxiga to standard care significantly reduced the relative risk of worsening renal function, progression to kidney failure, or risk of CV or renal death in certain patients with CKD, regardless of whether they had type 2 diabetes.

For additional analysis, see KOL Views Q&A: Leading nephrologist sizes up battle between SGLT2s, MRAs in CKD.

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