JW Jungwo Pharmaceutical's 'Hemlibra' First Proven to Reduce Bleeding in Korean Patients
The First Domestic Real-World Prescription Data Study on Severe Hemophilia A Patients with Inhibitors
Over 50% of Subjects Experienced No Bleeding After Hemlibra Administration
[Asia Economy Reporter Lee Gwan-joo] JW Pharmaceutical announced on the 3rd that it confirmed the bleeding reduction effect of Hemlibra (generic name: emicizumab) through a real-world data study conducted on domestic patients with severe hemophilia A.
Professor Han Seung-min of Yonsei University College of Medicine recently presented the results of a study on Hemlibra administration in domestic patients with severe hemophilia A at the 41st Autumn Academic Conference of the Korean Society on Thrombosis and Hemostasis held at Busan Port International Exhibition & Convention Center (BPEX). While overseas studies have proven Hemlibra's bleeding reduction effect, this is the first study to demonstrate the effect using actual prescription data from domestic patients.
Professor Han's team conducted the study jointly with four specialized hemophilia treatment medical institutions in Korea, including Gangdong Kyung Hee University Hospital and Keimyung University Dongsan Hospital. The study subjects were 15 patients with severe hemophilia A who were resistant to existing hemophilia treatments and had been administered Hemlibra for more than six months. The study results showed that after Hemlibra administration, the annualized joint bleeding rate (AJBR) was 0.48 for children and 0.90 for adults, with 66.7% of adults and 50.0% of children experiencing no bleeding.
The annualized bleeding rate (ABR) also significantly improved compared to before administration. The ABR before Hemlibra administration was 14.9, but it dropped sharply to 1.84 after administration. By age group, the pediatric group (ages 1.4 to 14.0) improved from 8.33 to 1.16, and the adult group (ages 20.6 to 48.3) improved from 19.3 to 2.29.
Professor Han said, “The bleeding prevention effect of Hemlibra for hemophilia A antibody patients, for whom bleeding control is difficult with existing bypassing agents (BPA), has been proven for the first time in Korea,” adding, “It is meaningful that this was confirmed for the first time using actual prescription data from domestic patients.”
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Hemlibra is a treatment for hemophilia A developed by Chugai Pharmaceutical, a Japanese subsidiary of the Swiss multinational pharmaceutical company Roche. JW Pharmaceutical secured domestic development and distribution rights in 2017 and received approval from the Ministry of Food and Drug Safety in 2019.
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