In which countries is Finerenone approved?

Introduction to Finerenone
Finerenone is a novel, non‐steroidal, selective mineralocorticoid receptor (MR) antagonist with a unique chemical structure and pharmacological profile that distinguishes it from traditional steroidal MR antagonists. Over recent years, extensive clinical research has demonstrated its efficacy in reducing kidney disease progression and cardiovascular events in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Finerenone is marketed under the trade name Kerendia and represents a major innovation in therapeutic options for patients with significant unmet clinical needs.

Chemical and Pharmacological Profile
Chemically, Finerenone is a small molecule designed to selectively inhibit the mineralocorticoid receptor. Unlike classical steroidal MR antagonists, which are associated with off‐target effects and a broad spectrum of side effects, Finerenone’s non‐steroidal profile allows for a more balanced tissue distribution between the heart and kidneys and results in a favorable adverse event profile. Its mechanism is predicated on blocking MR overactivation—a key driver in the pathological pathways that lead to renal fibrosis and inflammation as well as cardiovascular damage. This selectivity and balanced organ distribution have been substantiated by pharmacokinetic studies showing rapid absorption, a short half‐life enabling predictable dosing, and dose‐proportional increases in systemic exposure.

Therapeutic Indications
Originally developed by Bayer AG, Finerenone was intended for the treatment of diabetic nephropathies and to delay CKD progression among patients with T2D. The drug’s pivotal clinical studies, notably FIDELIO-DKD and FIGARO-DKD, have demonstrated its dual beneficial effects in reducing both renal and cardiovascular events. As a result, its approved indications include its use as an adjunct to standard care to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, and cardiovascular events in adults with CKD associated with T2D. The strategic development program of Finerenone also positions it as a potential disease-modifying therapeutic option that may address early as well as later stages of kidney dysfunction in these patients.

Regulatory Approval Process
The journey of Finerenone’s approval has been influenced by robust clinical data, efficient regulatory development strategies, and active engagement with regulatory bodies worldwide. Its regulatory milestones are a function of the comprehensive approval processes in major markets with stringent criteria requiring proof of efficacy and safety.

Overview of Drug Approval Processes in Major Markets
Drug approvals in major global markets are governed by distinct regulatory paradigms and processes. In the United States, the Food and Drug Administration (FDA) mandates rigorous clinical evaluation and a step‐wise review process via New Drug Applications (NDAs). In Europe, the centralized marketing authorization procedure is managed by the European Medicines Agency (EMA) in collaboration with the European Commission. In Asia, national agencies such as the Chinese National Medical Products Administration (NMPA) and Japan’s Ministry of Health, Labour, and Welfare (MHLW) follow their own review processes that often leverage both local and international clinical data. Additionally, Canada’s Health Canada provides its own regulatory framework for evaluating drug efficacy and safety. Finerenone’s approval across these jurisdictions has been driven by positive outcomes from large-scale, robust Phase III clinical trial programs, adherence to evolving regulatory standards, and engagements including priority review designations where applicable.

Key Regulatory Bodies
– The U.S. Food and Drug Administration (FDA) plays a central role in reviewing NDAs; Finerenone was granted approval based on its demonstrated benefit in reducing kidney and cardiovascular events, with its application receiving Priority Review to expedite patient access.
– In Europe, the European Medicines Agency (EMA) and subsequently the European Commission have reviewed and granted marketing authorization for Finerenone under the brand Kerendia, with its initial authorization coming in February 2022 and subsequent label extensions approved after additional data from the FIGARO-DKD study.
– In China, the Chinese National Medical Products Administration (NMPA) approved Finerenone (marketed as Kerendia or 可申达) based on both local and international clinical trial data, with approval confirmed in June 2022.
– In Japan, the Ministry of Health, Labour, and Welfare (MHLW) confirmed approval for Finerenone in March 2022 after evaluating data from pivotal Phase III studies and demonstrating its safety and efficacy in a large patient population.
– Health Canada, the regulatory authority for pharmaceutical products in Canada, approved Finerenone as an adjunct to standard of care for CKD and T2D in October 2022, reflecting the drug's international impact and validated clinical benefits in North American patient populations.

Global Approval Status of Finerenone
The regulatory achievements of Finerenone have been widely recognized across multiple major markets, reflecting its global potential and the trust placed in its clinical benefits by leading health authorities. The rigor of the clinical evidence and the proactive regulatory strategy have resulted in its approval in several jurisdictions with finalized regulatory decisions, while applications remain under review in other regions.

Approved Countries
Finerenone is currently approved for use in the following countries/regions, with each approval reflecting a milestone in a coordinated global approval effort:

• United States – Finerenone received approval from the U.S. FDA in July 2021. Under the FDA’s regulatory framework, the New Drug Application for Finerenone was supported by robust data from the FIDELIO-DKD and FIGARO-DKD trials, which established its clinical benefits in reducing kidney failure progression as well as cardiovascular events in CKD patients with T2D.

• European Union – The European Commission granted marketing authorization for Finerenone (commercially known as Kerendia) in February 2022. This approval was based on the compelling evidence from major Phase III trials, and the subsequent positive opinion from the Committee for Medicinal Products for Human Use (CHMP) supported its use in adult patients with chronic kidney disease associated with type 2 diabetes. The EU approval not only covers the later stages of CKD with albuminuria but has also been extended to include patients in the early stages of CKD based on further positive data from the FIGARO-DKD study.

• China – The Chinese National Medical Products Administration (NMPA) approved Finerenone in June 2022. In China, Finerenone is marketed under the brand Kerendia – the approval is supported by the evaluation of both local and international clinical trial data, underscoring its efficacy in reducing CKD progression and mitigating cardiovascular risk in T2D patients.

• Japan – Japan’s Ministry of Health, Labour, and Welfare (MHLW) granted approval for Finerenone in March 2022. The Japanese approval confirms the drug’s safety and efficacy in the local population, with the study data showing benefits even in patients with relatively early-stage CKD associated with type 2 diabetes. This move is critical in addressing the high prevalence of CKD in Japan and offers a novel treatment option that meets an unmet medical need.

• Canada – Health Canada approved Finerenone as an adjunct to standard of care therapy in adults with chronic kidney disease and type 2 diabetes in October 2022. The approval by Health Canada, as evidenced by detailed release notes, reflects the regulatory alignment with other major markets where Finerenone has demonstrated a clear therapeutic benefit and provides an additional tool for clinicians managing CKD progression and cardiovascular risks.

Each of the approvals mentioned above was achieved after a thorough evaluation of Finerenone’s clinical profile. The timing of these approvals, starting with the FDA in mid-2021 and followed by the European Commission, NMPA, MHLW, and Health Canada throughout 2021–2022, represents a cohesive global strategy by Bayer AG to address CKD in T2D patients. The approvals are supported by a considerable number of clinical studies (more than 13,000 patients were randomized across the FIDELIO-DKD and FIGARO-DKD trial programmes), ensuring that the clinical evidence is both robust and representative across diverse patient populations.

Pending Applications
While Finerenone has achieved regulatory approvals in major markets, additional applications are under review or pending authorization in other regions. Regulatory submissions have been made in other countries and regions where the burden of CKD and T2D is high. Some emerging markets in Latin America, parts of Asia, and potentially other jurisdictions in Europe have seen submissions, but approval decisions in these regions are still awaited. Bayer AG continues to engage with regulatory bodies internationally, with ongoing submissions indicating that Finerenone may soon expand its global footprint even further. The extensive clinical trial program and the compelling benefit-risk profile of Finerenone support the likelihood of its future approvals in these regions.

Implications of Approval
The broad global approval of Finerenone carries significant implications for both the pharmaceutical market and clinical practice. The regulatory endorsements across the United States, European Union, China, Japan, and Canada highlight how a well-executed clinical development plan can overcome regional barriers and culminate in widespread global acceptance.

Market Impact
The approval of Finerenone in multiple major markets underlines its potential to capture a significant share of the market for CKD and T2D treatments. From a business perspective, these approvals enable Bayer AG to enter diverse healthcare systems, each with unique market dynamics and reimbursement frameworks.
• In the United States and Canada, where the burden of diabetes-related CKD is substantial, Finerenone offers a targeted approach to delay disease progression and reduce cardiovascular morbidity, thus presenting a high-value option in the therapeutic arena.
• Within the European Union, the authorization for patients with early as well as later-stage CKD expands the potential patient population and supports the drug’s positioning as a disease-modifying therapy. The extended label approval is particularly important in demonstrating that Finerenone can meet the evolving regulatory expectations in markets with refined patient stratification and treatment guidelines.
• In China and Japan, where the prevalence of diabetes and CKD is high, the approvals provide critical treatment alternatives in healthcare systems that are under considerable pressure to manage chronic conditions effectively. The local approvals reinforce the robustness of Finerenone’s clinical data and its ability to translate efficacy across different ethnic and clinical contexts.

The synchrony of these approvals enhances Bayer’s strategic market positioning, ensuring that Finerenone is available in high-income as well as emerging markets. The resulting competitive advantage stems not only from an innovative mechanism of action and strong clinical data but also from the ability to rapidly bridge regulatory horizons across key geographies. As more countries grant approvals based on submissions that lean on shared clinical evidence and global development experiences, the pathway for Finerenone’s adoption becomes increasingly streamlined, fostering both market penetration and physician acceptance.

Clinical Implications
Clinically, the approvals of Finerenone signify a paradigm shift in the management of CKD in patients with T2D.
• The demonstrated ability of Finerenone to reduce proteinuria and slow the decline in kidney function, accompanied by a reduction in cardiovascular events, provides clinicians with an effective tool to intervene in a common clinical pathway that has historically been challenging to treat.
• The expanded label approvals, including those covering early-stage CKD, mean that physicians can consider Finerenone earlier in the disease course during a “window of opportunity” to prevent irreversible kidney damage and associated cardiovascular complications.
• Additionally, the favorable safety profile of Finerenone relative to traditional KRAs minimizes the risk of adverse events such as hyperkalemia when managed appropriately, making it a viable alternative or add-on therapy alongside existing treatment modalities.
• The availability of Finerenone across multiple jurisdictions also facilitates broader real-world evaluation as post-marketing surveillance programs (as seen in the regulatory updates provided by various agencies) further affirm its benefit-risk profile and inform refined dosing recommendations.

From an integrative perspective, the global approvals serve as a catalyst for clinical practice guidelines updates and the incorporation of Finerenone into treatment protocols for CKD associated with T2D. This regulatory endorsement not only validates the clinical trial endpoints but also promotes confidence among prescribers to adopt the therapy in routine practice. Moreover, as more healthcare providers observe tangible benefits in a heterogeneous patient population, further research and real-world evidence will continue to clarify its optimal use across various subgroups, reinforcing its role as a cornerstone in the management of diabetic nephropathies.

Conclusion
In conclusion, Finerenone has been approved in several key countries and regions, reflecting its efficacy and safety across diverse patient populations. It is currently approved in the United States by the FDA (July 2021), in the European Union by the European Commission (February 2022 with subsequent label extensions), in China by the National Medical Products Administration (June 2022), in Japan by the Ministry of Health, Labour, and Welfare (March 2022), and in Canada by Health Canada (October 2022). Each approval emerged from a meticulously designed clinical development program and harmonized regulatory submissions that underscore Finerenone’s potential as a transformative therapy for patients with CKD associated with T2D.

The regulatory journey of Finerenone—from its pharmacological innovation, through rigorous clinical trials, to its successful approvals in major global markets—exemplifies the integration of scientific innovation, strategic regulatory planning, and collaborative global development. The approvals not only ensure that patients in diverse regions can access this new treatment but also pave the way for future submissions in additional markets. Moreover, the clinical implications—ranging from improved kidney outcomes to reduced cardiovascular risk—signal a notable advancement in the treatment paradigms for CKD and T2D.

Overall, the global approval status of Finerenone reinforces its role as a significant advancement in nephrology and cardiometabolic care. Its continued evaluation through post-marketing surveillance and real-world evidence collection will further define its clinical utility while cementing its importance in the therapeutic landscape. The comprehensive approach taken by Bayer AG in securing approvals across the United States, European Union, China, Japan, and Canada sets a gold standard for global multi-regional regulatory success, ensuring that the benefits of Finerenone are widely disseminated and accessible to patients in need.