Tuesday, June 25, 2024
GSK plc (LSE/NYSE: GSK) announced today that Omjjara (momelotinib) has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for treating myelofibrosis. Omjjara is an oral inhibitor of JAK1/JAK2 and activin A receptor type 1 (ACVR1), taken once daily. This approval marks the fourth major regulatory milestone for momelotinib, following approvals by the US FDA as Ojjaara and under the brand Omjjara by the European Commission and the UK's MHRA.
Nina Mojas, Senior Vice President of Oncology Global Product Strategy at GSK, highlighted the heavy burden of myelofibrosis, which includes symptoms like spleen enlargement, fatigue, night sweats, and bone pain, often accompanied by anaemia requiring frequent blood transfusions. Mojas noted that the approval of Omjjara provides Japanese myelofibrosis patients with a new treatment option for this challenging blood cancer.
Myelofibrosis affects approximately 1 in 500,000 people globally, with an estimated 5,000 patients in Japan. Anaemia is prevalent among these patients and significantly impacts treatment outcomes and quality of life. The approval of Omjjara was supported by data from the MOMENTUM and SIMPLIFY-1 trials, demonstrating its efficacy and safety in treating myelofibrosis, particularly in anaemic and symptomatic patients.
Omjjara works by inhibiting JAK1, JAK2, and ACVR1 pathways, which can alleviate constitutional symptoms and splenomegaly and potentially benefit anaemia-related conditions by reducing hepcidin levels.
Omjjara’s indications, dosing, and safety considerations in Japan, consult the updated Product Information available through the Japan Pharmaceuticals and Medical Devices Agency.
Myelofibrosis is a rare blood cancer characterized by disrupted blood cell production due to dysregulated JAK-signal transducer and activator of transcription protein signalling. Clinical symptoms include enlarged spleen, low blood counts, and debilitating symptoms such as fatigue and bone pain.
GSK remains committed to advancing oncology treatments, focusing on innovations in immuno-oncology, targeted therapies, and advancements in hematologic malignancies to improve patient outcomes worldwide.
Source: gsk.com
