GSK 'Omjjara' expecting to get reimbursement greenlight

After failing last year's consideration, it will be re-attempted for the Drug Benefit Evaluation Committee (DBEC)

Options are lacking for anemia management…may resolve the current unmet needs

Product photo of Ojjaara/Omjjara

Previously failed at its first attempt, the new drug 'Omjjara' for treating myelofibrosis is eying another chance.

According to sources, GSK Korea's myelofibrosis treatment, Omjjara (momelotinib), is expected to be reviewed by this year's first Drug Benefit Evaluation Committee (DBEC) of the Health Insurance Review and Assessment Service (HIRA) today (January 15).

Omjjara passed the Cancer Drug Review Committee (CDRC) in March of last year. However, during the mediating process for the DEBC consideration, there has been a difference of opinion between GSK and HIRA regarding the designation of a substitute medicine for drug pricing, which has suspended the listing process. 

After that, GSK supplemented its documents last year, discussed with HIRA, and reached a positive conclusion for DBEC consideration. It will be watched to see whether Omjjara will succeed in finalizing the reimbursement listing process.

Omjjara has a triple mechanism of action that blocks JAK1, JAK2, and ACVR1 (activin A receptor type 1). In the treatment of myelofibrosis, inhibiting JAK1 and JAK2 can improve a patient's systemic symptoms and reduce enlarged spleen, while inhibiting ACVR1 can help alleviate anemia by decreasing hepcidin expression.

Anemia management is a key unmet need in the treatment of patients with existing myelofibrosis. Anemia, which increases transfusion dependency, is a problem beyond simple dizziness and can lead to severe, life-threatening conditions depending on its severity.

Based on the Phase 3 SIMPLIFY-1 and MOMENTUM clinical studies, Omjjara was shown to significantly reduce transfusion dependency and improve major symptoms, such as splenomegaly, in myelofibrosis patients with anemia, regardless of prior JAK inhibitor therapy.

In the SIMPLIFY-1 study, which confirmed the clinical efficacy and safety of Omjjara compared to Jakavi (ruxolitinib) in a first-line treatment setting for myelofibrosis patients who had no prior experience with JAK inhibitors, Omjjara demonstrated non-inferiority to ruxolitinib in spleen volume response at week 24, the primary endpoint.

The transfusion independence (TI) rate for each patient group was 66.5% in the Omjjara group and 49.3% in the ruxolitinib group, indicating that transfusion dependency was significantly lower in the Omjjara group.

Professor Seo-Yeon Ahn of the Department of Hematology-Oncology at Chonnam National University Hwasun Hospital stated, "JAK inhibitors previously used for drug treatment of myelofibrosis showed effects in alleviating splenomegaly and systemic symptoms. However, there were unmet needs such as worsening anemia or increasing transfusion dependency. Omjjara has confirmed significant clinical value in the prognosis of myelofibrosis patients and managing anemia."