Adempas may be prescribed at general hospitals in KOR

New pulmonary arterial hypertension drug reimbursed from June… its prescription to expand in Korea

Adempas, a new treatment for pulmonary arterial hypertension that has emerged after a long wait, is now available for prescription at general hospitals in Korea.

 

According to industry sources, Bayer Korea's Adempas (riociguat) has been approved by the Drug Committee (DC) of tertiary hospitals in Korea, including Samsung Medical Center and Seoul National University Hospital.

 

As it has been listed for reimbursement since this month (June), the number of medical institutions that can prescribe it is expected to continue to increase.

 

Adempas was approved in Korea as an orphan drug in June 2014 and is available in 5 dosage forms.

 

It is indicated for: ▲Improvement of exercise capacity in adult patients with chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) who are unable to undergo surgery or who have persistent or recurrent symptoms after surgery ▲Improvement of exercise capacity adult patients with pulmonary arterial hypertension (WHO Group 1) who are classified as having functional class II or III.

 

In particular, it was known as the first new drug for CTEPH.

 

CTEPH is caused by patients who develop chronic pulmonary embolism, which leads to fibrotic stenosis and occlusion, resulting in pathological vascular remodeling and increased resistance in the pulmonary artery.

 

CTEPH is a chronic disease that causes progressive dyspnea and right heart dysfunction, which weakens the heart.

 

Symptoms include dyspnea, fatigue, chest pain, dizziness, peripheral edema, cough, and hemoptysis, which reduces the patient’s quality of life.

 

Ultimately, it can progress to heart, kidney, and liver failure, which can lead to death.

 

Meanwhile, Adempas is a stimulator of soluble guanylate cyclase (sGC), an enzyme found in the heart and lungs, and its efficacy has been confirmed in two Phase III clinical trials in patients with chronic thromboembolic pulmonary hypertension.

 

Results showed improvement in exercise capacity, which was the primary endpoint, and good tolerability.

 

No unexpected adverse reactions were reported.

 

In the CHEST-1 study, when comparing the 6-minute walking test (6MWT) results after 16 weeks with the baseline, results showed that the group of patients who received riociguat showed statistically significant improvement compared to the group of patients who received placebo.

 

In the PATENT-1 study, the change in the 6MWT score after 12 weeks of treatment, showed statistically significant improvement in the riociguat arm compared to placebo, meeting the primary endpoint.