JW Pharma's hemophilia assay for patients using 'Hemlibra'

commercialized in KOR

A non-reimbursable criterion has been newly established for the chromogenic assay…can be used in combination with OSA test

"Expected to open a new treatment paradigm for diagnosing mild hemophilia·female hemophilia"

Product photo of Hemlibra.

JW Pharmaceutical announced on January 15 that its chromogenic assay designed to assess the severity of 'hemophilia' in patients using 'Hemlibra' has been commercialized in South Korea.

 

The Ministry of Health and Welfare (MOHW) has newly established a non-reimbursable CSA testing criterion, effective January 1.

 

CSA test is used to measure the activity of clotting factors in patients with hemophilia to diagnose the severity of the disease and to monitor the effectiveness of the treatment.

 

It is particularly effective in accurately measuring factor VIII, which is deficient in patients with Hemophilia A.

 

It is suitable for patients who use non-coagulant agents like Hemlibra.

 

The primary test used in South Korea is the One-Stage Clotting Assay (hereafter, OSA test).

 

However, the OSA test is limited in accurately diagnosing patients with mild symptoms and confirming the severity of hemophilia in patients treated with Hemlibra.

 

For this reason, the World Federation of Hemophilia (WFH) recommends a combination of OSA and CSA.

 

CSA testing is recommended for testing the severity of hemophilia in patients using Hemlibra and hemostasis testing after factor VIII combination therapy.

 

"The commercialization of the CSA test allows for assessing hemophilia severity in patients treated with Hemlibra," said Dr.

 

Park Young-sil, professor of pediatrics at Kyung Hee University Hospital at Gangdong.

 

"It will also improve the diagnostic environment for patients with mild symptoms and female hemophilia patients (carriers) who could not be accurately diagnosed using the existing OSA test." "The commercialization of the CSA test will significantly advance hemophilia diagnosis and treatment," said a representative from JW Pharmaceutical.

 

"We will strive to improve patient access to treatments and the quality of life for patients with hemophilia A."