JW Pharmaceutical said Wednesday that a study demonstrating the effectiveness and safety of Hemlibra (emicizumab), a treatment for hemophilia A, in Korean patients, was recently published in the international journal Haemophilia.

This is the first time that real-world data evaluating the efficacy and safety of Hemlibra in Koreans with severe hemophilia A antibodies has been published in an international journal.

A research team led by Dr. Han Seung-min, a professor at the Department of Pediatrics at Yonsei University College of Medicine, studied 16 Korean patients (nine adults and seven children) with severe hemophilia A antibodies who took Hemlibra for more than six months between March 2021 and October 2022.

According to the 2021 White Paper on Hemophilia published by the Korea Hemophilia Foundation, 1,778 people lived with hemophilia A in Korea. Of these, 1,270, or 71.4 percent, were severe, including 26 patients with antibodies (hyper-antibodies).

The researchers evaluated patients' average annual bleed rate (ABR) and adverse events before and after taking Hemlibra.

Results showed that the median ABR significantly decreased from 10.5 (0-48) times before treatment with Hemlibra to 0.00 times (0.00-1.47) after treatment (p<0.001). It declined from 7.0 times (2-12) to 0.35 times (0.00-0.99) among children. Among adults, it fell 14.0 times (0-48) to 0.00 times (0.00-1.47). After treatment with Hemlibra, patients had a median annual joint bleeding rate (AJBR) of 0.00 times (0.00-1.24) among children. Among children and adults, AJBR was 0.00 times (0.00-0.35) and 0.00 times (0.00-1.24).

Nine patients showed zero bleeds -- no bleeding requiring treatment -- during the study, representing 56.3 percent of the total.

Regarding safety, no drug-related adverse events occurred after treatment with Hemlibra.

"This study is significant because it confirmed the efficacy and safety of Hemlibra through actual prescription data of severe hemophilia A antibody patients in Korea," a company official said. "We expect more hemophilia A patients to benefit from this treatment as health insurance coverage was expanded to non-antibody severe patients in May."

Hemlibra is a hemophilia A treatment developed by Japan's Chugai Pharmaceutical, a subsidiary of global pharmaceutical giant Roche. JW Pharm secured the rights to develop and distribute Hemlibra in Korea in 2017 and received approval from the Ministry of Food and Drug Safety in 2019.

Hemlibra is a new drug that mimics factor 8, a blood clotting factor lacking in the body of hemophilia patients. It is the only treatment for hemophilia A used for antibody- and non-antibody-patients resistant to existing treatment of factor 8 drugs.