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FDA Approves Label Expansion of BAYRY's Kidney Disease Drug Kerendia
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Key Takeaways
Bayer's Kerendia is now approved in the U.S. for adults with CKD associated with T1D.
Kerendia cut UACR 25% from baseline over six months versus placebo in the FINE-ONE trial.
Kerendia sales jumped 82.9% in the second quarter, driven by higher U.S. and China volumes.
Bayer (BAYRY - Free Report) announced that the FDA has approved a label expansion for kidney disease drug Kerendia (finerenone) for the treatment of adult patients with chronic kidney disease (CKD) associated with type one diabetes (T1D).
The drug is a selective, non-steroidal mineralocorticoid receptor antagonist.
In the United States, Kerendia was initially approved in 2021 to treat adults with CKD associated with type 2 diabetes (T2D). The drug’s label was expanded in 2025 to include the treatment of adults with symptomatic chronic heart failure with a left ventricular ejection fraction (LVEF) of at least 40%. With the latest approval, Kerendia is now also indicated for adults with CKD associated with T1D.
More on BAYRY’s Kerendia Label Expansion
The FDA approval of Kerendia’s expanded indication addresses an important unmet need, as approximately 30% of people with type 1 diabetes in the United States develop CKD, putting them at increased risk of kidney failure.
The approval follows the FDA’s Priority Review designation and is supported by positive results from the pivotal phase III FINE-ONE study. In the trial, Kerendia, when added to standard of care, demonstrated a statistically significant 25% reduction from baseline in the urine albumin-to-creatinine ratio (UACR) over six months compared with placebo in adults with CKD associated with T1D.
The expanded indication broadens Kerendia’s addressable patient population and strengthens its growth prospects by extending its use into an underserved T1D population. This marks Kerendia’s third approved indication in the United States, further expanding its role in treating patients with kidney and cardiovascular diseases and potentially supporting sustained demand for the drug.
The drug is also marketed as Firialta in some countries.
It is approved for the treatment of adult patients with CKD associated T2D in China, Europe and Japan. Finerenone is also approved for the treatment of heart failure with LVEF of at least 40% in Europe, Japan, China and several other markets.
Applications for marketing authorization of finerenone for the treatment of non-diabetic CKD have been filed in China and Japan.
Year to date, BAYRY’s shares have risen 29.8% compared with the industry’s 10.9% growth.
Image Source: Zacks Investment Research
BAYRY’s Efforts to Boost Portfolio
Bayer has put up a decent performance year to date. Key drugs like Nubeqa and Kerendia boosted Pharmaceuticals sales, enabling the company to combat declines in Eylea and Xarelto following patent expirations.
Sales of Kerendia skyrocketed 82.9% in the second quarter, fueled by a substantial rise in volumes in the United States and China.
Label expansion of key drugs and approval of additional drugs will further boost sales from this business. The recent FDA approval of elinzanetant for the treatment of moderate to severe menopause-related vasomotor symptoms, under the brand name Lynkuet, is a significant boost for the company.
Bayer Aktiengesellschaft Price, Consensus and EPS Surprise
In cardiovascular disease, the FDA accepted applications for asundexian for the prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack, with Priority Review designation.
In radiology, the FDA approved Ambelvist (gadoquatrane) in June for contrast-enhanced MRI in adult and pediatric patients.
Bayer has a collaboration agreement with Regeneron (REGN - Free Report) for ophthalmology drug Eylea.
REGN records net product sales of Eylea and Eylea 8 mg in the United States. BAYRY records net product sales of Eylea outside the country. REGN records its share of profits and losses from the sale of Eylea outside the United States.
Bayer also has a collaboration agreement with Johnson & Johnson (JNJ - Free Report) for Xarelto. In the U.S. market, Xarelto is marketed by J&J. Bayer earns license revenues from JNJ for Xarelto sales in the United States.
View the Zacks #1 Rank List
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FDA Approves Label Expansion of BAYRY's Kidney Disease Drug Kerendia
Key Takeaways
Bayer (BAYRY - Free Report) announced that the FDA has approved a label expansion for kidney disease drug Kerendia (finerenone) for the treatment of adult patients with chronic kidney disease (CKD) associated with type one diabetes (T1D).
The drug is a selective, non-steroidal mineralocorticoid receptor antagonist.
In the United States, Kerendia was initially approved in 2021 to treat adults with CKD associated with type 2 diabetes (T2D). The drug’s label was expanded in 2025 to include the treatment of adults with symptomatic chronic heart failure with a left ventricular ejection fraction (LVEF) of at least 40%. With the latest approval, Kerendia is now also indicated for adults with CKD associated with T1D.
More on BAYRY’s Kerendia Label Expansion
The FDA approval of Kerendia’s expanded indication addresses an important unmet need, as approximately 30% of people with type 1 diabetes in the United States develop CKD, putting them at increased risk of kidney failure.
The approval follows the FDA’s Priority Review designation and is supported by positive results from the pivotal phase III FINE-ONE study. In the trial, Kerendia, when added to standard of care, demonstrated a statistically significant 25% reduction from baseline in the urine albumin-to-creatinine ratio (UACR) over six months compared with placebo in adults with CKD associated with T1D.
The expanded indication broadens Kerendia’s addressable patient population and strengthens its growth prospects by extending its use into an underserved T1D population. This marks Kerendia’s third approved indication in the United States, further expanding its role in treating patients with kidney and cardiovascular diseases and potentially supporting sustained demand for the drug.
The drug is also marketed as Firialta in some countries.
It is approved for the treatment of adult patients with CKD associated T2D in China, Europe and Japan. Finerenone is also approved for the treatment of heart failure with LVEF of at least 40% in Europe, Japan, China and several other markets.
Applications for marketing authorization of finerenone for the treatment of non-diabetic CKD have been filed in China and Japan.
Year to date, BAYRY’s shares have risen 29.8% compared with the industry’s 10.9% growth.
Image Source: Zacks Investment Research
BAYRY’s Efforts to Boost Portfolio
Bayer has put up a decent performance year to date. Key drugs like Nubeqa and Kerendia boosted Pharmaceuticals sales, enabling the company to combat declines in Eylea and Xarelto following patent expirations.
Sales of Kerendia skyrocketed 82.9% in the second quarter, fueled by a substantial rise in volumes in the United States and China.
Label expansion of key drugs and approval of additional drugs will further boost sales from this business. The recent FDA approval of elinzanetant for the treatment of moderate to severe menopause-related vasomotor symptoms, under the brand name Lynkuet, is a significant boost for the company.
Bayer Aktiengesellschaft Price, Consensus and EPS Surprise
Bayer Aktiengesellschaft price-consensus-eps-surprise-chart | Bayer Aktiengesellschaft Quote
In cardiovascular disease, the FDA accepted applications for asundexian for the prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack, with Priority Review designation.
In radiology, the FDA approved Ambelvist (gadoquatrane) in June for contrast-enhanced MRI in adult and pediatric patients.
Bayer has a collaboration agreement with Regeneron (REGN - Free Report) for ophthalmology drug Eylea.
REGN records net product sales of Eylea and Eylea 8 mg in the United States. BAYRY records net product sales of Eylea outside the country. REGN records its share of profits and losses from the sale of Eylea outside the United States.
Bayer also has a collaboration agreement with Johnson & Johnson (JNJ - Free Report) for Xarelto. In the U.S. market, Xarelto is marketed by J&J. Bayer earns license revenues from JNJ for Xarelto sales in the United States.
Bayer’s Zacks Rank
BAYRY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.