Bayer releases 2 new CVD drugs with reimb in KOR

Increasing influence in the cardiovascular drug treatment mkt

Releases heart failure drug ‘Verquvo’ and kidney disease drug ‘Kerendia’ with reimbursement in Korea

Bayer Korea, which has been slow to launch new drugs, is making a comeback, recently succeeding in reimbursing two of its cardiovascular drugs in Korea.

 

According to industry sources, Bayer Korea launched its heart failure drug ‘Verquvo (vericiguat)’ with reimbursement on September 1 last year and its kidney disease drug ‘Kerendia (finerenone)’ on February 1 this year.

 

The addition of the two drugs is expected to revitalize Bayer's cardiovascular division, which did not have a prominent pipeline since the launch of its novel oral anticoagulant (NOAC) ‘Xarelto (rivaroxaban).’

Verquvo, the first sGC stimulator for heart failure Verquvo was approved in December 2021 as a combination therapy in Korea as a treatment to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient intravenous (iv) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.

 

Conventional heart failure treatments work by blocking the harmful effects of the natural neurohormonal system that is activated by myocardial and vascular dysfunction.

 

In contrast, Verquvo is a soluble sGC stimulator that has a novel mechanism of action to improve myocardial and vascular function by catalyzing the synthesis of intracellular cyclic guanosine monophosphate (cGMP), which regulates cardiac contractility, vascular tone, and cardiac remodeling.

 

It is the first-in-class sGC stimulator approved for the treatment of chronic heart failure.

 

The Phase III VICTORIA trial, which became the basis for Verquvo’s approval, was shown to reduce the risk of hospitalization in patients with heart failure.

 

A total of 5,050 patients were enrolled in the study, including 1,132 Asian patients.

 

Study results showed that at a median of 10.8 months of follow-up, the risk of death from cardiovascular disease or first hospitalization due to heart failure was about 10% lower in the Verquvo group than that of the placebo group, and the trial met its primary efficacy endpoint with an annual absolute risk reduction of 4.2%.

 

Kerendia, the first kidney failure drug introduced in 20 years Kerendia was approved in Korea in May 2022 by the KFDA for the treatment of adult patients with chronic kidney disease (CKD) and Type 2 diabetes to reduce the risk of end-stage kidney disease (ESKD) and a sustained decline in estimated glomerular filtration rate (eGFR), and cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure.

 

Until now, only treatments that target hemodynamic changes and metabolic abnormalities, 2 of the 3 causes that worsen chronic kidney disease in type 2 diabetes, had existed, but the introduction of Kerendia made available a treatment that inhibits inflammation and fibrosis in the kidneys.

 

Kerendia’s reimbursement approval was based on the reduction in kidney disease progression, cardiovascular benefit, and safety that was demonstrated through the Phase III trials FIDELIO-DKD and FIGARO-DKD.

 

In the FIDELIO-DKD study, Kerendia significantly reduced the incidence of a sustained decline in eGFR of ≥ 40%, kidney failure (defined as chronic dialysis, kidney transplantation, or a sustained decrease in eGFR to < 15 mL/min/1.73 m2 ), or renal death by 18% compared with placebo.