ONO Receives a Manufacturing and Marketing Approval for ® Coralan Tablet for the Treatment of Chronic Heart Failure in Japan Ono Pharmaceutical Co., Ltd. (Osaka, Japan, President and Representative Director: Gyo Sagara; ® "ONO") announced today that it received a manufacturing and marketing approval of Coralan (generic name: ivabradine hydrochloride) 2.5mg, 5mg and 7.5mg ("Coralan"), a HCN (hyperpolarization-activated cyclic nucleotide-gated) channel blocker, for the treatment of patients with chronic heart failure with sinus rhythm and baseline resting heart rate ≥75 beats per minute (limited to patients receiving standard treatment of chronic heart failure, including β-blocker) in Japan.
This approval is mainly based on the results from the following two clinical studies: *1
1) A multi-center, randomized, double blind, placebo controlled study (J-SHIFT study) , conducted in Japan in 254 patients with chronic heart failure (CHF): NYHA (New York Heart Association) class II to IV, resting heart rate ≥75 beats per minute in sinus rhythm, and left ventricular ejection fraction (LVEF) ≤35% under optimal background therapy, and *2
2) A multi-center, randomized, double blind, placebo controlled study (SHIFT study) , conducted overseas in 6,505 patients with CHF (resting heart rate ≥70 beats per minute in sinus rhythm) similar to the J-SHIFT study.
Heart failure is defined as a clinical syndrome in which dyspnea, fatigue and edema appear as a result of failure of compensatory function of the cardiac pump due to cardiac dysfunction, resulting in a decrease in exercise tolerance. CHF is the condition where the situation of HF chronically 3 continues, and the number of patients with CHF in Japan is estimated to reach 1.2 million in 2020* . The drugs used for the treatment of CHF include angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists, β-blockers, anti-aldosterone drugs, diuretics, etc. for the purpose of controlling symptoms of patients, preventing hospitalization, and avoiding death in patients with CHF.
In patients with CHF, the heart rate tends to increase to compensate for the inability of the heart to exert sufficient blood volume leading to put more strain on the heart. In addition, it has been shown that higher heart rates have a negative impact on the prognosis in patients with CHF. Coralan provides a new treatment options for patients with high heart rate even if they take existing drugs for the treatment of CHF.
*1 ： Tsutsui H, Momomura S, Yamashina A, et al. Efficacy and safety of ivabradine in Japanese patients with chronic heart failure －J-SHIFT Study. Circ J 2019. doi: 10.1253/circj.CJ-19- 0227.
*2 ： Swedberg K, Komajda M, Böhm M et al. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet 2010; 376:875-85
*3 ： Guidelines for Diagnosis and Treatment of Acute and Chronic Heart Failure. (JCS 2017/JHFS 2017)
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