JW Pharmaceutical reaffirmed the long-term safety and clinical value of Hemlibra, a treatment for hemophilia A. The company presented real-world data (RWD) demonstrating not only bleeding prevention but also improvements in patients' quality of life.
On June 24, JW Pharmaceutical announced that it held the 'HAVEN-SEVEN Symposium' on June 13 at the Westin Chosun Parnas in Gangnam, Seoul, to commemorate the 7th anniversary of Hemlibra's approval in South Korea.
The symposium aimed to share long-term safety data and accumulated RWD from real clinical settings with healthcare professionals treating hemophilia in the country.
Hemlibra is a bispecific antibody treatment designed to mimic the function of the missing blood coagulation factor VIII in patients with hemophilia A. It can be administered subcutaneously once every four weeks. Since its approval in South Korea in 2019, the health insurance coverage has expanded to include non-antibody patients aged one year and older as of 2023.
During the symposium, Professor Park Young-sil from Kangdong Kyunghee University Hospital presented on the topic of 'Safety Evidence Confirmed by Global Data and Domestic RWD.' She shared data from over 24,000 patients accumulated over a decade since the global launch, stating, "Despite the increase in patient numbers, the incidence rate of severe thromboembolism remained low at 0.17 cases per 100 patients observed over one year."
Professor Han Jung-woo from Yonsei University Severance Hospital discussed 'Bleeding Prevention and Management Related to Increased Activity Levels in Hemlibra Patients.' He noted, "The treatment goals for hemophilia are expanding beyond just bleeding prevention to include improvements in physical activity and quality of life. A study tracking 112 hemophilia A patients who exercised regularly for 12 months found that the frequency of exercise or participation in high-risk sports did not directly increase bleeding risk, with only 0.2% of all exercise-related incidents linked to bleeding after transitioning to Hemlibra."
Professor Baek Hee-jo from Hwasun Chonnam National University Hospital spoke on 'Quality of Life and Joint Health in Hemophilia Patients.' He emphasized, "In a treatment environment with a low annual bleeding rate (ABR), relying solely on ABR metrics may not adequately assess patient status, and it is essential to consider supplementary indicators such as joint health, patient-reported outcomes, and treatment burden."
Additionally, a study published in the international journal 'TH Open' in April highlighted that pediatric and adolescent patients receiving Hemlibra maintained a low bleeding risk while engaging in various physical activities, supporting the treatment's effectiveness. JW Pharmaceutical plans to share treatment strategies based on long-term safety and real-world data for Hemlibra, aiming to create a patient-centered treatment environment.
A JW Pharmaceutical representative stated, "This symposium confirmed the long-term safety and clinical value of Hemlibra in real-world settings, and we will continue to engage in academic exchanges with healthcare professionals."
* This article has been translated by AI.
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