New test enables patients using Hemlibra to assess their hemophilia severity

Chromogenic assay (CSA), a test that can assess the severity of hemophilia in patients taking Hemlibra, a treatment for hemophilia A, will be commercialized soon, making it easier to evaluate Hemlibra's hemostatic ability.

JW Pharmaceutical said Wednesday that the CSA test has been newly established as an unreimbursed item for health insurance, effective Jan. 1.

The CSA test is a diagnostic method used to measure the activity of clotting factors in hemophilia patients to diagnose the severity of the disease and monitor the effectiveness of treatment. Notably, it can precisely measure the activity of factor 8, which is deficient in hemophilia A patients, and is also suitable for patients using non-clotting factor drugs, such as Hemlibra.

In Korea, the One-Stage Clotting Assay (OSA) test has been used in the past. However, the OSA test had limitations, including low accuracy in diagnosing mild cases and difficulty identifying the severity of Hemlibra patients.

Therefore, the World Federation of Hemophilia (WFH) recommends a combination of OSA and CSA testing. CSA testing is recommended for hemophilia severity testing in patients receiving Hemlibra and hemostasis testing after factor-8 combination therapy.

“The commercialization of the CSA test has made it possible to assess the severity of hemophilia in patients receiving Hemlibra,” said Dr. Park Young-sil, professor of pediatrics at Kyung Hee University Hospital at Gangdong. “It will also improve the diagnostic environment for mild and female hemophilia patients (carriers) who could not be accurately diagnosed using the existing OSA test.”

A JW Pharmaceutical official said, “The commercialization of the CSA test will contribute significantly to the advancement of hemophilia diagnosis and treatment,” said a representative from JW Pharmaceutical. “We will continue to do our best to improve access to treatment and the quality of life for hemophilia A patients.”

Hemlibra is an innovative new drug that mimics factor 8, a blood clotting factor deficient in hemophilia A patients. It uses bispecific antibody technology that binds to factors 9 and 10.

Hemlibra is the only hemophilia A treatment that can be used by both antibody and non-antibody patients who are resistant to existing treatments (factor 8 agents). Subcutaneous injections once a week for up to four weeks sustain the prophylactic effect.