BMS’s oHCM drug Camzyos approved in Korea

,a treatment for obstructive hypertrophic cardiomyopathy

First cardiac myosin inhibitor that specifically targets the source of oHCM.

Demonstrated significant improvement in heart function and exercise capacity

BMS Korea (Country Manager: Hye Young Lee) announced on the 24th that the Ministry of Food and Drug Safety has approved the company’s obstructive hypertrophic cardiomyopathy (oHCM) treatment ‘Camzyos (mavacamten)’ to treat adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve exercise capacity and symptoms.

 

Camzyos is the first and only FDA-approved cardiac myosin inhibitor that specifically targets excess myosin actin cross-bridge formation, which is the main cause of oHCM.

 

Camzyos can improve left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin and relaxing the over-contracted heart muscle.

 

oHCM is a rare disease that occurs when the left ventricular muscle of the heart becomes abnormally thick, obstructing blood flow through the aorta to the rest of the body.

 

Its main symptoms are shortness of breath, dizziness, chest pain, fainting, etc., which appear in various ways and can increase the risk of various cardiovascular complications such as heart failure and atrial fibrillation.

 

It can cause sudden cardiac death during exercise, especially in young adults and children aged 10 to 35 years.

 

There had remained a high unmet need for the treatment oHCM as its treatment focused more on symptom relief than fundamental cure.

 

Treatment options such as beta-blockers and non-dihydropyridine calcium channel blockers can reduce the heart rate and myocardial contractility, but it is difficult to expect long-term improvement with these existing drug treatment options alone.

 

In addition to this, other available options involve surgically removing the enlarged myocardium or injecting alcohol to cause necrosis of the muscle area, but such procedures are performed to a limited extent due to high risk.

 

Sang-Chol Lee, Professor of Cardiology at Samsung Medical Center, said, “oHCM is a serious and rare condition that can even cause sudden cardiac death without warning.

 

We had much difficulty with its treatment as no effective method of treatment had been available for the non-invasive treatment of the enlarged heart structure, which led to patients experiencing worsening symptoms.

 

Camzyos is the first cardiac myosin inhibitor that specifically targets the source of oHCM.

 

The drug, which only needs to be administered orally once a day, showed excellent symptom improvement effect from the beginning of treatment, and is expected to help restore the quality of life for our patients.” The Phase III EXPLORER-HCM trial, which served as the basis for approval, Camzyos demonstrated statistically significant improvements in heart function and exercise capacity compared to placebo.

 

In the trial, the composite primary endpoint was set as the proportion of patients who achieved either an improvement of mixed venous oxygen tension (pVO2) plus maintenance or improvement in NYHA class.

 

Trial results showed twice more patients receiving Camzyos achieved the primary endpoint compared to the placebo.

 

In particular, 20% of the patients that received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement, and the heart function of half of those patients treated with Camzyos had improved to Class I, the mildest stage.

 

The treatment effects of Camzyos remained consistent throughout the study for 30 weeks.

 

Also, the left ventricular outflow tract (LVOT) gradient improved to the extent that 70% of the patients would not consider surgery.

 

The proportion of patients who improved below the LVOT pressure difference of 50mmHg, which is the standard considered for surgery, showed a large difference of more than 50%, with 74% in the Camzyos arm and 21% in the placebo arm.

 

The proportion of patients who improved to less than 30 mmHg, which is even lower, was also 57% in the Camzyos group, which was higher than the 7% in the placebo group.

 

BMS Korea’s Country Manager Hye Young Lee, said “We are pleased to be able to provide a fundamental treatment benefit with Camzyos for Korean patients with oHCM who have been experiencing worsening symptoms, to the extent that patients had difficulty continuing on their daily life and were at risk of sudden death.

 

We hope that the approval of Camzyos will be able to contribute not only to the treatment of domestic oHCM patients but also to restore their normal daily life," he said.