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Bayer Seeks Kerendia Label Expansion in Non-Diabetic CKD
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Key Takeaways
Bayer's Kerendia sNDA gains FDA acceptance for CKD patients without diabetes.
Kerendia significantly delayed kidney disease progression and reduced cardiovascular-kidney events.
Bayer is expanding Kerendia's label across CKD and heart failure through its phase III program.
Bayer (BAYRY - Free Report) is moving to expand the addressable market for Kerendia (finerenone), with the FDA accepting the company’s supplemental new drug application (sNDA) for adults with chronic kidney disease (CKD) without diabetes.
The drug is a selective, non-steroidal mineralocorticoid receptor antagonist.
The regulatory filing is based on positive phase III FIND-CKD data and represents a potentially important growth opportunity for the drug.
Results from the study demonstrated that finerenone significantly delayed kidney disease progression and reduced cardiovascular-kidney events in addition to standard of care versus placebo in adults with CKD without diabetes.
It should be noted that Kerendia is currently approved for CKD associated with type 2 diabetes in more than 100 countries and for heart failure with left ventricular ejection fraction of at least 40% in several major markets. An approval in non-diabetic CKD would significantly broaden its patient population and further strengthen Bayer’s cardiovascular and renal franchise.
The drug is also marketed as Firialta in some countries.
BAYER’s Efforts to Expand Kerendia’s Label
Last month, the FDA approved Kerendia for the treatment of adult patients with CKD associated with type one diabetes.
The approval was supported by positive results from the pivotal phase III FINE-ONE study. In the study, Kerendia, when added to standard of care, demonstrated a statistically significant 25% reduction from baseline in the urine albumin-to-creatinine ratio over six months compared with placebo in adults with CKD associated with type one diabetes.
Kerendia is also being evaluated in a broad phase III development program spanning CKD and heart failure, providing additional opportunities to extend the drug’s commercial lifecycle.
The FINEOVATE clinical development program includes twelve phase III studies across CKD and heart failure (HF). The CKD-focused THUNDERBALL program includes the completed phase III studies FIDELIO-DKD, FIGARO-DKD, FIND-CKD and FINE-ONE, along with the phase II CONFIDENCE study and ongoing pediatric phase III studies FIONA and FIONA-OLE. The HF-focused MOONRAKER program comprises the completed pivotal phase III FINEARTS-HF study, ongoing investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF and FINALITY-HF, and the pediatric phase III studies FIORE and FIORELLO.
BAYRY’s Efforts to Boost Portfolio
Bayer has put up a decent performance year to date, with strong growth from key pharmaceutical products helping the company offset sales declines from established blockbusters facing patent-related pressures. Nubeqa and Kerendia have emerged as important growth drivers, while a series of recent and potential regulatory approvals could provide additional support to the Pharmaceuticals business.
Year to date, BAYRY’s shares have risen 13.3% compared with the industry’s 11.8% growth.
Image Source: Zacks Investment Research
Kerendia has been one of Bayer’s strongest-performing drugs. Second-quarter sales increased 82.9%, driven by substantial volume growth in the United States and China.
Nubeqa is another important growth product for Bayer and is benefiting from increasing demand in prostate cancer. Continued expansion of its use and penetration in eligible patients could help support the business as older products face competition.
Bayer is also strengthening its portfolio through new product approvals. The FDA recently approved elinzanetant, marketed as Lynkuet, for the treatment of moderate to severe menopause-related vasomotor symptoms. The approval gives Bayer an opportunity to establish a presence in a large women’s health market and diversify its growth beyond oncology and cardiovascular therapies.
In cardiovascular disease, the FDA accepted Bayer’s application for asundexian for the prevention of ischemic stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack. The application received Priority Review designation. While the commercial opportunity will ultimately depend on regulatory approval and clinical differentiation, asundexian represents another potential pipeline contributor.
Bayer has also expanded its radiology portfolio. The FDA approved Ambelvist (gadoquatrane) in June for contrast-enhanced magnetic resonance imaging in adult and pediatric patients. The approval adds another product to Bayer’s radiology franchise and provides an additional source of pharmaceutical revenue.
However, Bayer continues to face challenges from patent expirations affecting some of its biggest established medicines.
Bayer has a collaboration agreement with Regeneron (REGN - Free Report) for the 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.
The product’s mature lifecycle and increasing competitive pressures create a headwind for Bayer’s Pharmaceuticals business.
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Bayer Seeks Kerendia Label Expansion in Non-Diabetic CKD
Key Takeaways
Bayer (BAYRY - Free Report) is moving to expand the addressable market for Kerendia (finerenone), with the FDA accepting the company’s supplemental new drug application (sNDA) for adults with chronic kidney disease (CKD) without diabetes.
The drug is a selective, non-steroidal mineralocorticoid receptor antagonist.
The regulatory filing is based on positive phase III FIND-CKD data and represents a potentially important growth opportunity for the drug.
Results from the study demonstrated that finerenone significantly delayed kidney disease progression and reduced cardiovascular-kidney events in addition to standard of care versus placebo in adults with CKD without diabetes.
It should be noted that Kerendia is currently approved for CKD associated with type 2 diabetes in more than 100 countries and for heart failure with left ventricular ejection fraction of at least 40% in several major markets. An approval in non-diabetic CKD would significantly broaden its patient population and further strengthen Bayer’s cardiovascular and renal franchise.
The drug is also marketed as Firialta in some countries.
BAYER’s Efforts to Expand Kerendia’s Label
Last month, the FDA approved Kerendia for the treatment of adult patients with CKD associated with type one diabetes.
The approval was supported by positive results from the pivotal phase III FINE-ONE study. In the study, Kerendia, when added to standard of care, demonstrated a statistically significant 25% reduction from baseline in the urine albumin-to-creatinine ratio over six months compared with placebo in adults with CKD associated with type one diabetes.
Kerendia is also being evaluated in a broad phase III development program spanning CKD and heart failure, providing additional opportunities to extend the drug’s commercial lifecycle.
The FINEOVATE clinical development program includes twelve phase III studies across CKD and heart failure (HF). The CKD-focused THUNDERBALL program includes the completed phase III studies FIDELIO-DKD, FIGARO-DKD, FIND-CKD and FINE-ONE, along with the phase II CONFIDENCE study and ongoing pediatric phase III studies FIONA and FIONA-OLE. The HF-focused MOONRAKER program comprises the completed pivotal phase III FINEARTS-HF study, ongoing investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF and FINALITY-HF, and the pediatric phase III studies FIORE and FIORELLO.
BAYRY’s Efforts to Boost Portfolio
Bayer has put up a decent performance year to date, with strong growth from key pharmaceutical products helping the company offset sales declines from established blockbusters facing patent-related pressures. Nubeqa and Kerendia have emerged as important growth drivers, while a series of recent and potential regulatory approvals could provide additional support to the Pharmaceuticals business.
Year to date, BAYRY’s shares have risen 13.3% compared with the industry’s 11.8% growth.
Image Source: Zacks Investment Research
Kerendia has been one of Bayer’s strongest-performing drugs. Second-quarter sales increased 82.9%, driven by substantial volume growth in the United States and China.
Nubeqa is another important growth product for Bayer and is benefiting from increasing demand in prostate cancer. Continued expansion of its use and penetration in eligible patients could help support the business as older products face competition.
Bayer is also strengthening its portfolio through new product approvals. The FDA recently approved elinzanetant, marketed as Lynkuet, for the treatment of moderate to severe menopause-related vasomotor symptoms. The approval gives Bayer an opportunity to establish a presence in a large women’s health market and diversify its growth beyond oncology and cardiovascular therapies.
In cardiovascular disease, the FDA accepted Bayer’s application for asundexian for the prevention of ischemic stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack. The application received Priority Review designation. While the commercial opportunity will ultimately depend on regulatory approval and clinical differentiation, asundexian represents another potential pipeline contributor.
Bayer has also expanded its radiology portfolio. The FDA approved Ambelvist (gadoquatrane) in June for contrast-enhanced magnetic resonance imaging in adult and pediatric patients. The approval adds another product to Bayer’s radiology franchise and provides an additional source of pharmaceutical revenue.
However, Bayer continues to face challenges from patent expirations affecting some of its biggest established medicines.
Bayer has a collaboration agreement with Regeneron (REGN - Free Report) for the 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.
The product’s mature lifecycle and increasing competitive pressures create a headwind for Bayer’s Pharmaceuticals business.
Bayer’s Zacks Rank
BAYRY currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.