MFDS Grants Import Approval for Rare Drug Treating Myelofibrosis

Approval of 'Omjjara-jeong' product... Expanding treatment options

The Ministry of Food and Drug Safety announced on the 25th that GlaxoSmithKline has been approved to import the rare myelofibrosis drug 'Omzara Tablets (active ingredient Momelotinib)'.

Myelofibrosis is one of the myeloproliferative neoplasms, causing fibrosis in the bone marrow tissue responsible for hematopoiesis, leading to impaired blood production function.

Omzara Tablets are used to treat intermediate or high-risk myelofibrosis in adults with anemia (primary myelofibrosis, post-polycythemia vera myelofibrosis, post-essential thrombocythemia myelofibrosis).

This drug exerts its therapeutic effect by binding to the Janus kinase enzyme involved in excessive proliferation and fibrosis of bone marrow cells. Additionally, it inhibits activin A receptor type 1, which causes anemia in myelofibrosis patients, thereby alleviating anemia symptoms and is expected to provide new treatment opportunities for myelofibrosis patients with anemia, the Ministry of Food and Drug Safety explained.