GSK Canada's submission for momelotinib for the treatment of myelofibrosis accepted for review by Health Canada

30 Jan 2024
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Phase 3Clinical ResultCell Therapy
[30-January-2024] Health Canada's acceptance of the submission follows that of the Ministry of Health, Labour and Welfare (WHLW) in Japan and approval by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Regulatory submission includes data from pivotal trials addressing key clinical manifestations of myelofibrosis, namely splenomegaly, constitutional symptoms and anemia. MISSISSAUGA ON, Jan. 30, 2024 /CNW/ - GSK announces that Heath Canada has accepted into review the New Drug Submission (NDS) for momelotinib, a potential new medicine with a differentiated mechanism of action that may help address the significant medical needs of myelofibrosis patients, especially those with anemia. The NDS is based on key phase III trials SIMPLIFY-1 and MOMENTUM. Myelofibrosis is a rare blood cancer that can lead to splenomegaly (enlarged spleen); constitutional symptoms such as fatigue, night sweats, and bone pain; and severely low blood counts, including anemia and thrombocytopenia. [1][2][3] Approximately 82% [4] of patients diagnosed with myelofibrosis are intermediate or high-risk and about one-third to one-half of patients are anemic at the time of diagnosis. [5][6][7] The majority of myelofibrosis patients are expected to develop anemia over the course of the disease, and those who are transfusion dependent have a poor prognosis and shortened survival. [8][9][10][11][12][13][14][15][16] Momelotinib is an investigational product that is not currently authorized for sale in Canada. About momelotinib Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signaling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, type I (ACVR1). [17][18][19][20] Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly. [17][19][20] Additionally, inhibition of ACVR1 leads to a decrease in circulating hepcidin, which is elevated in myelofibrosis and contributes to anemia. [17][18][19][20] About myelofibrosis Myelofibrosis is a rare blood cancer that disrupts the body's normal production of blood cells as a result of dysregulated JAK-signal transducer and activator of transcription protein signaling. The clinical hallmarks of myelofibrosis are progressive splenomegaly (enlarged spleen), anemia and debilitating symptoms attributable to ineffective hematopoiesis and excessive production of proinflammatory cytokines. [21] Myelofibrosis patients with anemia require additional supportive care, including transfusions, and have poor outcomes. [22][23] An estimated 1,400-2,177 patients are living with myelofibrosis in Canada with an estimated 3 in 500,000 people worldwide affected. [24][25] About the pivotal SIMPLIFY-1 clinical trial SIMPLIFY-1 was a global randomized, double-blind, phase III study that compared the safety and efficacy of momelotinib to ruxolitinib in patients with myelofibrosis who had not received prior treatment with a JAK inhibitorJAK inhibitor. About the pivotal MOMENTUM clinical trial MOMENTUM was a global, randomized, double-blind phase III clinical trial that compared the safety and efficacy of momelotinib to danazol in patients with myelofibrosis who were symptomatic and anemic and had been previously treated with an approved JAK inhibitorJAK inhibitor. The trial was designed to evaluate the safety and efficacy of momelotinib for treating and reducing key hallmarks of the disease: symptoms, blood transfusions (due to anemia) and splenomegaly. GSK in oncology GSK is committed to maximizing patient survival through transformational medicines, with a current focus on breakthroughs in immuno-oncology and tumor-cell targeting therapies, and development in hematologic malignancies, gynecologic cancers and other solid tumors. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilizing modalities such as small molecules, antibodies, antibody-drug conjugates, and cell therapy, either alone or in combination. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. For further information please visit . GSK Media Enquiries +1 855 593 6274 References SOURCE GlaxoSmithKline Inc.
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