JW Pharmaceutical's Hemophilia A Treatment 'Hemlibra' Included in WHO Essential Medicines List

JW Pharmaceutical announced on October 20 that its hemophilia A treatment 'Hemlibra' (ingredient name: emicizumab) has been newly included in the 2025 revised edition of the World Health Organization (WHO) Essential Medicines List (EML) and Essential Medicines List for Children (EMLc).

JW Pharmaceutical's hemophilia treatment 'Hemlibra'. JW Pharmaceutical

Hemlibra is a bispecific antibody treatment designed to mimic the function of coagulation factor VIII. It is the only prophylactic treatment available for both hemophilia A patients who have developed inhibitors to factor VIII products and those who have not. In addition, its once-every-four-weeks subcutaneous injection provides sustained bleeding prevention, significantly improving convenience compared to conventional intravenous infusions.

The WHO Essential Medicines List serves as a reference document for national public procurement and health insurance reimbursement policies. The World Federation of Hemophilia (WFH) officially requested the inclusion of Hemlibra in the WHO list, submitting multicenter, long-term clinical results and cost-effectiveness data, which were reflected in the WHO's evaluation process.

This inclusion took into comprehensive account Hemlibra’s consistently demonstrated prophylactic efficacy and safety in various global clinical trials, as well as its high level of dosing convenience.

In global clinical trials conducted to date, Hemlibra has consistently maintained a low annualized bleeding rate (ABR) regardless of age or inhibitor status, and has been shown to reduce joint bleeding and help maintain joint function.

In terms of safety, most adverse reactions were predictable and manageable. The most common adverse reaction was injection site pain, which was generally mild to moderate. Rare cases of thrombosis have been reported when used in combination with high doses of activated prothrombin complex concentrate (aPCC), but the risk can be minimized by adhering to recommended guidelines.

Furthermore, as a subcutaneous injection, Hemlibra allows patients to choose dosing intervals of 1, 2, or 4 weeks according to their condition and preference, reducing the burden of hospital visits and improving treatment adherence. This contributes to achieving the core goals of prophylactic therapy: bleeding prevention and restoration of daily life.

A JW Pharmaceutical official stated, "The inclusion of Hemlibra in the WHO Essential Medicines List is international recognition of its clinical value and safety. We will make every effort to ensure that domestic hemophilia A patients can benefit from more stable and continuous prophylactic treatment with Hemlibra as a result of this listing."

Meanwhile, Hemlibra is a hemophilia A treatment developed by Chugai Pharmaceutical, a subsidiary of global pharmaceutical company Roche. JW Pharmaceutical secured domestic development and distribution rights for Hemlibra in 2017 and obtained approval from the Ministry of Food and Drug Safety in 2019.

This content was produced with the assistance of AI translation services.