JW Pharmaceutical: Hemlibra Again Shown to Prevent Bleeding in Pediatric Hemophilia A

Meta-analysis of 18 studies and 720 patients
"0.5 annual bleeding events, zero intracranial hemorrhage"

JW Pharmaceutical announced on the 4th that the results of a meta-analysis evaluating the preventive effect against bleeding and the safety of Hemlibra (ingredient name: emicizumab), a treatment for hemophilia A, in pediatric patients have been published in the international journal "Haemophilia".

This study was conducted by a research team at the National and Kapodistrian University of Athens in Greece. The team integrated 18 existing studies on Hemlibra prophylaxis and analyzed clinical data from 720 pediatric patients with hemophilia A.

Hemlibra product advertisement image. JW Pharmaceutical

The analysis showed that the median annualized bleeding rate (ABR) in patients treated with Hemlibra was 0.5 events. The prevalence of joint bleeding, which can lead to long-term disability, was 5.4%.

In terms of safety indicators, there were no reported cases of intracranial hemorrhage (ICH), which is classified as a severe complication. In contrast, a previous meta-analysis of 45 studies involving pediatric and adolescent patients under 25 years of age who used conventional therapies before the introduction of Hemlibra estimated the incidence of intracranial hemorrhage at 7.4 events per 1,000 patients followed for one year. There were 5 reported cases of anti-drug antibodies (ADA) against Hemlibra, but no clear association with reduced efficacy was identified. The researchers emphasized that the rate of fatal intracranial hemorrhage, which had previously been at the level of 2.1 cases per 100 newborns, decreased to 0 cases after the introduction of Hemlibra.

Hemlibra is a bispecific antibody-based therapy that mimics the function of coagulation factor VIII. It can be used regardless of inhibitor status. A key feature is that its preventive effect can be maintained with a subcutaneous injection administered as infrequently as once every four weeks. In Korea, as of May 2023, National Health Insurance reimbursement coverage was expanded to include patients aged 1 year or older with severe hemophilia A without inhibitors. In September last year, it was added to the World Health Organization (WHO) Model List of Essential Medicines and the Model List of Essential Medicines for Children.

JW Pharmaceutical stated that it plans to continue building clinical evidence to improve the treatment environment and enhance treatment accessibility for pediatric patients with hemophilia.

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