Potential blockbuster drug Kerendia…1yr since reimbursement

Posted KRW 5.2 billion in sales since being granted reimbursement in February last year… Sales exceeded KRW 1 billion in December

Attention is gathered to whether the drug can address the unmet demand for a drug that can directly inhibit chronic inflammation and renal fibrosis

Increased prescriptions in endocrinology and nephrology departments... Expectations rise on its increasing influence with the approval of additional indications

The prescription performance of Kerendia (finerenone), Bayer’s treatment for chronic kidney disease in adults with type 2 diabetes, has been increasing since it was granted reimbursement last year.

 

With its monthly sales recording KRW 1 billion in the last month of last year, the drug is rapidly building up its performance, and given its growth, it is likely to become a blockbuster treatment in Korea this year.

 

Pic of Kerendia Tab

Kerendia is a first-in-class, selective, non-steroidal mineralocorticoid receptor antagonist(MRA) that inhibits the overactivation of mineralocorticoid receptors, which can cause inflammation and fibrosis in the kidneys, kidneys, and blood vessels.

 

Kerendia, which was approved in Korea in May 2022, was approved for insurance reimbursement benefits on February 1 of last year, about a year and a half after its approval in Korea.

 

The standards for Kerendia’s reimbursement are as follows: Adult patients with type 2 diabetes who have been taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) for more than four weeks, but have ▲a urinary albumin-to-creatinine ratio (uACR) over 300 mg/g or a urine dipstick test result of 1+ or higher, and ▲an estimated glomerular filtration rate (If eGFR is between 25 and 75, the drug may be administered together with ACE inhibitors and ARBs).

 

Kerendia gained the spotlight as diabetes accounts for the highest proportion (38.6%) among the causes of end-stage renal disease.

 

Until now, drugs to control blood pressure and reduce the burden on the kidneys were used with GLP-1 and SGLT-2 inhibitors to control blood sugar, but there was an unmet need.

 

In particular, as there had been no drug that could directly suppress chronic inflammation or fibrosis of the kidneys, Kerendia, which has a new mechanism of action that can directly target these, is expected to play a greater role.

 

“So far, GLP-1 receptor agonists, SGLT-2 inhibitors, and RAS inhibitors, which are blood pressure medications, have been used to treat patients with diabetes and kidney disease, but the risk of chronic kidney disease persisted in the patients,” said Yong-Ho Lee, Professor of endocrinology at Severance Hospital and Director of General Affairs of the Korean Diabetes Association.

 

“As Kerendia has proven its efficacy in various clinical trials, it will become an important treatment option for patients with chronic kidney disease,” he said.

 

Monthly Sales of Bayer

In fact, Kerendia‘s sales have been growing since its reimbursement in Korea.

 

After being granted reimbursement last year, Kerendia’s monthly sales started at KRW 30 million in March and continued to rise, reaching KRW 100 million in April.

 

In particular, the company recorded monthly sales of KRW 1 billion in December, the last month of last year, and is expected to continue to increase its influence this year.

 

Looking at the quarterly figures, the company showed twofold growth each quarter, posting KRW 800 million in the second quarter, KRW 1.7 billion in the third quarter, and KRW 2.7 billion in the fourth quarter.

 

Taking this into account, sales are expected to easily exceed the KRW 10 billion mark which is the threshold for a blockbuster drug in Korea, within this year.

 

The expansion of the prescription of Kerendia seems to have been influenced by its characteristics as a treatment for chronic kidney disease patients with Type 2 diabetes.

 

According to UBIST, prescriptions increased significantly in the early days after the reimbursement was applied, mainly in the field of nephrology, but the number of prescriptions in the field of endocrinology also increased from September, and in December, when monthly sales reached KRW 1 billion, the number of prescriptions in the field of nephrology and endocrinology did not differ significantly.

 

Quarterly Sales of Bayer

In this situation, the drug’s influence in the market is expected to continue to grow as Bayer Korea announced plans to expand Kerendia’s indications.

 

On November 20, 2019, the Ministry of Food and Drug Safety approved a randomized clinical trial to determine the efficacy and safety of finerenone on the morbidity and mortality of heart failure patients with a left ventricular ejection fraction of 40% or more who were hospitalized due to an acute non-reversible episode of heart failure.

 

It can be regarded as a domestic version of the Phase III FINEARTS-HF trial, which evaluated Kerendia in patients with heart failure with a left ventricular ejection fraction of 40% or more, which was announced at the European Society of Cardiology's annual conference (ESC 2024) in September last year.

 

As Kerendia has already been shown to prevent heart failure-related secondary events in patients with heart failure with reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF), which have ejection fraction 40% or higher, the indication expansion in Korea is not expected to be difficult if there are no major variables.