Omjjara may be prescribed at general hospitals in KOR

lands in 13 medical institutions, including SMC, St. Mary's Hospital, and AMC

Passed Cancer Review Committee in March... Expected to be submitted to the Drug Reimbursement Evaluation Committee in the second half of the year

The new myelofibrosis drug ‘Omjjara’ can now be prescribed in general hospitals in Korea.

 

According to industry sources, GSK Korea's myelofibrosis treatment Omjjara (momelotinib) recently passed review by Drug Committees (DCs) of 13 medical institutions, including Samsung Medical Center, Seoul St.

 

Mary's Hospital, Asan Medical Center Seoul, Kyungpook National University Hospital, Dong-A University Hospital, Seoul National University Bundang Hospital, Ulsan University Hospital, Eunpyeong St.

 

Mary's Hospital, and Ewha Womans University Mokdong Hospital.

 

With the drug’s insurance reimbursement listing in progress, the drug is expected to quickly lead to actual prescriptions once listed.

 

Omjjara passed the Health Insurance Review and Assessment Service's Cancer Review Committee review in March and is currently awaiting submission to the Drug Reimbursement Evaluation Committee.

 

It remains to be seen whether the HIRA process will be completed by the end of this year.

 

The indication currently under review is for the “treatment of myelofibrosis in intermediate- or high-risk adults with anemia.” Omjjara has a triple mechanism of action – it blocks 3 key signaling pathways, not only JAK1 and JAK2 that were inhibited by existing therapies, but also the ACVR1 (activin A receptor type).

 

In the treatment of myelofibrosis, inhibition of JAK1 and JAK2 may contribute to improving systemic symptoms and reducing splenomegaly in patients, while inhibition of ACVR1 may help alleviate anemia by inducing a reduction in hepcidin expression.

 

Anemia management is one of the unmet needs that remain in the treatment of existing myelofibrosis patients.

 

Anemia, which increases blood transfusion dependency, is not merely an issue of dizziness as commonly perceived, but can lead to a life-threatening condition depending on its severity.

 

Omjjara demonstrated significant improvements in key symptoms such as splenomegaly and a reduction in transfusion dependency in patients with anemia-associated myelofibrosis, regardless of prior JAK inhibitor treatment history, in the Phase III SIMPLIFY-1 study and the MOMENTUM study.

 

In the SIMPLIFY-1 study, which evaluated the clinical efficacy and safety of Omjjara in comparison with Jakavi (ruxolitinib) in patients with myelofibrosis and had no prior JAK inhibitor treatment experience, Omjjara demonstrated non-inferiority to ruxolitinib in the primary endpoint of spleen volume response at 24 weeks of treatment.

 

The proportion of patients in each arm who were transfusion-free was 66.5% in the Omjjara arm and 49.3% in the ruxolitinib arm, with significantly lower transfusion dependence (better transfusion independence) in the Omjjara arm.

 

Seo-Yeon Ahn, Professor of Hematology at Chonnam National University Hwasun Hospital, said, “While JAK inhibitors previously used in the treatment of myelofibrosis demonstrated efficacy in reducing splenomegaly and alleviating systemic symptoms, they also posed unmet needs such as worsening anemia or increasing blood transfusion dependency.

 

Omjjara has demonstrated significant clinical value in managing anemia, which is closely linked to the prognosis of patients with myelofibrosis.

 

With its domestic launch, it is expected to contribute to improving treatment outcomes and quality of life for more patients."