GSK and the pan-Canadian Pharmaceutical Alliance (pCPA) agree to a letter of intent (LOI) for Ojjaara for the treatment of myelofibrosis in adults who have moderate to severe anemia
MISSISSAUGA, ONTARIO - GSK today announced that it successfully entered into a letter of intent (LOI) with the with the pan-Canadian Pharmaceutical Alliance (pCPA) for Ojjaara (momelotinib) for the treatment of myelofibrosis in adults who have moderate to severe anemia, marking a significant milestone towards making Ojjaara accessible through public funding.
With an LOI in place, GSK Canada will now initiate discussions with provinces and territories to secure the listing of Ojjaara under their publicly funded programs, an important step to ensuring this treatment becomes available to patients living with this rare disease.
“We welcome the pCPA team’s collaboration and diligence as we reach this important milestone for myelofibrosis patients in Canada,” said Sridhar Venkatesh, President & General Manager, GSK Canada. “Ojjaara exemplifies our dedication to delivering innovative therapies that address unmet medical needs, and we look forward to working with provincial, territorial, and federal drug plans to make it available through public reimbursement to patients across the country.”
The successful conclusion of pCPA negotiations underscores GSK Canada's commitment to driving innovation in hematology-oncology and improving patient outcomes, while continuing to expedite the next steps toward public reimbursement to ensure treatments addressing unmet needs become accessible to Canadian patients.
“For Canadians living with myelofibrosis, anemia is a challenging and debilitating complication of the disease that profoundly affects their quality of life,” said Cheryl Petruk, CEO, HEAL Canada. “The completion of negotiations between GSK and the pCPA represents hope for patients and caregivers who have been waiting for additional treatment options for this rare blood cancer. We’re encouraged by the progress and look forward to seeing Ojjaara made available through public funding.”
Ojjaara is the only approved medication that treats myelofibrosis with moderate to severe anemia and other key manifestations of myelofibrosis.1 It was approved by Health Canada in November 2024.
About Myelofibrosis
Myelofibrosis is a condition where too many abnormal blood cells are produced in the bone marrow – the spongy insides of bone where blood cells develop, causing scar tissue to build up in the marrow, eventually leading to a decrease in normal red blood cells, white blood cells, and platelets production.2 To compensate, the spleen and liver may enlarge as these organs take on the role of making more blood cells.2 In Canada, 1,400 to 2,177 patients have been diagnosed with myelofibrosis.3 It is typically diagnosed in people between 50 and 80 years old but can occur at any age.4
About Ojjaara
Ojjaara is the only once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.1 In Canada, Ojjaara is indicated for the treatment of splenomegaly and/or disease-related symptoms, in adult patients with intermediate or high-risk primary myelofibrosis (MF), post polycythemia vera MF or post essential thrombocythemia MF who have moderate to severe anemia.1
Please consult the Product Monograph at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q1 Results for 2025.
References
1 Ojjaara Canadian Product Monograph
Harrison C, et al. Presented at: European Hematology Association; June 2022. Poster EP1113
2 The Chronic Myelogenous Leukemia Society of Canada. Myelofibrosis – FACT Sheet. Available at: https://cmlsociety.org/myelofibrosis-fact-sheet/#_edn8
3 Heppner et al. BMC Res Notes (2019) 12:286.
4 The Leukemia & Lymphoma Society. Idiopathic myelofibrosis. 2007. Available at http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/mpd/pdf/idiopathicmyelofibrosis.pdf