(Health Korea News / Lee Chang-yong) BMS’s overactive occlusive hypertrophic cardiopathy (oHCM) treatment Camzyos (ingredient name: mavacamten) has shown positive results in long-term clinical trials.
BMS announced at the European Society of Cardiology (ESC) Congress held in London on the 2nd of this month that it confirmed sustained improvements in ultrasound measurements and biomarkers after administering Kamziox to patients with obstructive hypertrophic cardiopathy and following them for up to 180 weeks.
This study was conducted on 251 patients with oHCM in New York Heart Association (NYHA) class II–III. All patients had a left ventricular ejection fraction (LVEF) of 55% or more and a left ventricular outflow tract (LVOT) gradient of 50 mmHg or more. The NYHA class is a classification system for assessing symptoms in patients with heart failure. Patients with NYHA class II–III may have difficulty in daily life due to symptoms such as dyspnea.
In the clinical trial, all patients started on Kamzios 5 mg. Kamzios dose was adjusted every 4 weeks.
The LVOT gradient is an indicator of blood flow resistance between the left ventricle and the aorta in patients with hypertrophic HCM, and is considered normal if it is less than 20 mmHg. LVEF is the left ventricular ejection fraction. It is a figure that expresses the amount of blood pumped out by the left ventricle in a single heartbeat as a percentage. Normal LVEF is between 55% and 70%.
The study found that 66.3% (166 patients) of patients achieved NYHA class 1 at 180 weeks after starting treatment. NYHA class 1 is a class in which there are no symptoms of heart failure and no restrictions on daily life.
The LVOT gradient decreased by 40.2 mmHg. The mean left ventricular ejection fraction (LVEF) remained within the normal range (63.9%). The HCM Symptom Questionnaire (HCMSQ) also showed that short-term dyspnea scores improved during the first 12 weeks.
“These results, which represent the longest follow-up of any Phase 3 study to date, underscore the safety and efficacy of Camzyos,” said Dr. Roland Chen, vice president of immunology, cardiovascular and neuroscience development at Bristol-Myers Squibb.
Obstructive hypertrophic cardiopathy is a rare disease in which the heart muscle thickens. The left ventricular wall thickens and the path through which blood flows (left ventricular outflow tract, LVOT) becomes narrow. This blockage of blood flow is called obstructive.
Patients with this disease may easily become tired, experience shortness of breath, palpitations, dizziness, and chest pain. If the degree of ventricular wall thickening is severe, fainting may occur. There are 2,745 known patients with obstructive hypertrophic heart disease in Korea.
Meanwhile, the Ministry of Food and Drug Safety of Korea approved ‘Kamjios Capsule’ in 4 doses (2.5mg, 5mg, 10mg, 15mg) as an orphan drug in May 2023. The indication was the treatment of symptomatic (NYHA class II-III) obstructive hypertrophic cardiomyopathy (oHCM). ‘Kamjios’ was the first treatment for HCM to be approved in Korea.
Kamzios has suffered a bitter defeat during the process of listing benefits. In June, BMS Korea requested the Health Insurance Review & Assessment Service to review the eligibility of Kamzios for health insurance benefits, but it was not successful.
Kamzios challenged the salary listing again in July, and was reviewed for salary appropriateness at the 7th Pharmaceutical Affairs Committee in 2024.
Copyright © Health Korea News. Unauthorized reproduction and redistribution prohibited.
Source: www.hkn24.com
