JW Pharmaceutical’s Hemlibra earns spot on WHO’s 2025 essential medicines list for hemophilia A

JW Pharmaceutical said Monday that its hemophilia A treatment, Hemlibra (ingredient: emicizumab), has been newly added to the World Health Organization’s (WHO) Model List of Essential Medicines (EML) and the Model List of Essential Medicines for Children (EMLc) in the 2025 revision.

JW Pharmaceutical’s Hemlibra, a preventive therapy for hemophilia A, has been newly listed on the WHO’s 2025 Model List of Essential Medicines and Essential Medicines for Children. (Credit: JW Pharmaceutical)

Developed by Chugai Pharmaceutical, a subsidiary of Roche, Hemlibra was licensed to JW Pharmaceutical in 2017 for development and commercialization in Korea. It received marketing approval from the Ministry of Food and Drug Safety in 2019.

Hemlibra is a bispecific antibody designed to mimic the function of coagulation factor VIII. It is the only prophylactic treatment available for patients with hemophilia A, regardless of whether they have developed inhibitors to factor VIII replacement therapy.

The drug is administered subcutaneously as infrequently as once every four weeks, offering sustained prevention of bleeding episodes and greatly improved convenience compared to conventional intravenous injections.

The WHO’s EML serves as a key reference for national governments when shaping public procurement and reimbursement policies. The World Federation of Hemophilia (WFH) officially requested the inclusion of Hemlibra, submitting data from multiple long-term clinical studies and cost-effectiveness analyses. These materials were reflected in WHO’s review process, ultimately supporting the drug’s addition to the list.

The decision was based on Hemlibra’s consistent efficacy and safety demonstrated across global clinical trials. The treatment maintained a low annualized bleeding rate (ABR) regardless of age or inhibitor status and showed significant benefits in reducing joint bleeds and preserving joint function.

Most adverse reactions were predictable and manageable, with injection-site pain reported as the most common event, typically mild to moderate in severity.

Although rare cases of thrombosis have been observed when used with high doses of activated prothrombin complex concentrate (aPCC), adherence to recommended guidelines minimizes such risks.

In addition to its safety and efficacy, Hemlibra’s flexible dosing schedule -- every one, two, or four weeks depending on patient condition and preference -- helps reduce hospital visits and improve adherence, supporting the treatment’s goal of preventing bleeds and enabling a return to normal daily life.

“The WHO’s inclusion of Hemlibra as an essential medicine is an international recognition of its clinical value and safety,” a JW Pharmaceutical official said. “We will continue our efforts to ensure that Korean patients with hemophilia A can benefit from stable and long-term preventive treatment with Hemlibra.”