"Winrevair, gamechanger for pulmonary arterial hypertension"

New treatment that has emerged after over 20 years…the first-in-class Activin Signaling Inhibitor (ASI) is garnering attention

Based on the STELLAR study, Winrevair improved 6-minute walk distance (6MWD) and reduced mortality risk by 84%

Quickly included in the global treatment guidelines…expected to be included in the treatment guideline in Korea within this year

Winrevair (sotatercept), a new mechanism treatment for pulmonary arterial hypertension that has emerged after over 20 years, has been approved in Korea.

 

Consequently, competitive market is expected.

 

Although reimbursement remains a challenge, it is expected to change the treatment paradigm for pulmonary hypertension, a disease with significant unmet needs, by addressing the fundamental cause of the disease.

 

Dr.

 

Wook-Jin Chung, President of the Korean Society of Pulmonary Hypertension

MSD Korea held a press conference on August 12, celebrating the approval of Winrevair and highlighting the drug's role and value.

 

Pulmonary hypertension is not simply a state of constricted blood vessels.

 

It is a disease of structural narrowing where the walls of the pulmonary arterioles thicken and their lumens become constricted, making it different from general hypertension.

 

Dr.

 

Wook-Jin Chung, President of the Korean Society of Pulmonary Hypertension (Professor of Cardiology at Gachon University Gil Medical Center), explained, "Pulmonary hypertension patients suffer from shortness of breath, cough, fatigue, and fainting as the disease advances.

 

However, due to a complex diagnostic process, patients experience a diagnostic odyssey that can take up to three years." "Pulmonary hypertension patients experience such severe shortness of breath that even walking becomes difficult, leading to serious limitations in all aspects of daily life, including exercise, childcare, housework, and social activities.

 

In severe cases, it can be fatal, with a risk of sudden death." For high-risk patients, the probability of death within one year exceeds 20%, and approximately 30% of domestic patients still die within five years of diagnosis.

 

Until now, phosphodiesterase-5 (PDE5) inhibitors and calcium channel blockers (CCBs) have been used, but they have only been effective in controlling symptoms.

 

Dr.

 

Chung said, "Pulmonary hypertension is both a rare, intractable disease and a chronic condition, so there was an urgent need for a treatment strategy that could restore a healthy daily life to patients." In relation to this, the newly approved Winrevair is generating high expectations because it approaches the fundamental cause of the disease.

 

Winrevair is the first-in-class Activin Signaling Inhibitor (ASI), utilizing the 'Activin' pathway, which is one of the pathogenic mechanisms of pulmonary hypertension.

 

This treatment demonstrates the potential for reverse remodeling by inhibiting the proliferation of abnormally thickened blood vessels, thereby reversing the remodeling of pulmonary arterioles and the right ventricle.

 

In a study of 323 pulmonary hypertension patients, the Winrevair group's 6-minute walk distance (6MWD) increased by 40.1 m, while the placebo group's decreased by 1.4 m.

 

Additionally, Winrevair reduced the risk of clinical worsening or death from all causes related to pulmonary hypertension by 84%.

 

Kyung-hee Kim, Chairperson of the Clinical Guidelines Committee of the Korean Society of Pulmonary Hypertension, said, "Experts from the clinical guidelines committees in Europe and the United States have recommended the addition of ASI when updating pulmonary hypertension treatment guidelines," and added, "The Korean Society of Pulmonary Hypertension is also reviewing the inclusion of ASI in the pulmonary hypertension treatment guidelines in Korea."

Dr.

 

Kyung-hee Kim, Chairperson of the Clinical Guidelines Committee of the Korean Society of Pulmonary Hypertension

Winrevair was approved through the Ministry of Food and Drug Safety's 'Concurrent Approval-Evaluation-Negotiation Pilot Program' and has quickly entered the reimbursement review process.

 

The Ministry of Health and Welfare (MOHW) has been running the 'Concurrent Approval-Evaluation-Negotiation Pilot Program' since 2023 to improve access to treatment for life-threatening, severe, and rare diseases.

 

The project conducts approval, reimbursement evaluation, and drug price negotiations simultaneously, aiming to shorten the time required for new drugs to be included in the National Health Insurance list.

 

Dr.

 

Chung emphasized, "For patients to benefit from Winrevair, it must be quickly covered by national health insurance." He added, "Even if the treatment is expensive, and its efficacy has been proven overseas, efforts are necessary to ensure it can be used, even if strict criteria are applied."