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Health Canada Approves GSK’s Ojjaara for Myelofibrosis in Patients Having Moderate to Severe Anaemia

14 Nov 2024
Admin
News Article

Health Canada Approves GSK’s Ojjaara for Myelofibrosis in Patients Having Moderate to Severe Anaemia

Health Canada approves GSK’s Ojjaara for the treatment of myelofibrosis in adults who have moderate to severe anaemia

Overview

GSK announced that Health Canada has approved Ojjaara (momelotinib) 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 anaemia. Ojjaara is the first and only approved medication globally, and now in Canada, that treats both the anaemia and other key manifestations of myelofibrosis (newly diagnosed and previously treated).

Statement from GSK Canada

“Treatment options for myelofibrosis-related anaemia have been limited. We are proud to offer this treatment alternative for Canadian patients to address this critical unmet need and other myelofibrosis symptoms.”
“With most myelofibrosis patients becoming anaemic over time, Ojjaara’s approval represents a significant milestone to improve the outcomes of these patients while also highlighting GSK’s commitment to making an impact in Canada’s haematology oncology space through innovative new treatments,” said Michelle Horn, interim country medical director, GSK Canada.

Myelofibrosis: Epidemiology, Symptoms, and a Survey

Myelofibrosis is a rare blood cancer part of the broader myeloproliferative neoplasms (MPNs) diseases.
MPNs have an incidence rate of 2.05 new cases per 100,000 Canadians. Currently there are between 1,400-2,177 estimated people living with this type of disease in Canada.
Anaemia is a common symptom of myelofibrosis and a major unmet need, but awareness among Canadians is low.
A 2024 survey shows that 90% of Canadians have heard of anaemia but almost 50 per cent do not know about blood cancer related anaemia.
Canadians also have low knowledge of anaemia with over 40 per cent of the same respondents saying they know little to nothing about this condition.

Statement from the CEO: HEAL Canada

“Anaemia and related transfusions significantly affect the quality of life, prognosis and survival for anaemic myelofibrosis patients,” said Cheryl Petruk, CEO of HEAL Canada.
“We are excited to witness progress in this rare disease space and to see Ojjaara approved in Canada. This new treatment has the potential to help improve the lives of patients while addressing the disease’s main challenges, namely anaemia and other major symptoms.”

About the Drug: Ojjaara

Ojjaara is the only once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.
The approval of Ojjaara by Health Canada is supported by data from the pivotal MOMENTUM phase III trial, which demonstrated significant improvements in Total Symptom Score (TSS), Transfusion Independence, and Splenic Response Rate.
Additional support came from a subset of patients in the SIMPLIFY-1 phase III trial, reinforcing Ojjaara’s efficacy in treating moderate to severe anaemia and related symptoms in myelofibrosis patients.

About the Rare Disease: Myelofibrosis

Myelofibrosis is a condition where too many 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.
To compensate, the spleen and liver may enlarge as these organs take on the role of making more blood cells.
In Canada, 1,400 to 2,177 patients have been diagnosed with myelofibrosis. It is typically diagnosed in people between 50 and 80 years old but can occur at any age.

About Anaemia

Anaemia is one of the most common and serious complications of myelofibrosis and is often associated with poor overall survival, reduced quality of life, and the need for frequent blood transfusions.
Nearly all people with myelofibrosis are estimated to develop anaemia over the course of the disease.
Research has shown that over 32% of patients with myelofibrosis taking a current available JAK inhibitor will discontinue treatment due to anaemia.

The MOMENTUM Trial

MOMENTUM was a phase III, global, multicentre, randomised, double-blind study investigating momelotinib versus danazol in patients with myelofibrosis who were symptomatic and anaemic and had been previously treated with an approved JAK 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 anaemia) and splenomegaly.
Results from the 24-week treatment period were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in The Lancet.

The SIMPLIFY-1 Trial

SIMPLIFY-1 was a multicentre, randomised, 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 inhibitor.
Safety and efficacy results for SIMPLIFY-1 were based upon a subset of patients with moderate to severe anaemia (haemoglobin <10 g/dL) at baseline.
The efficacy of momelotinib in the treatment of patients with myelofibrosis in SIMPLIFY-1 was based on spleen volume response (reduction by 35 per cent or greater).

Ojjaara: MOA

Ojjaara has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, type I (ACVR1).
Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.
Additionally, inhibition of ACVR1 leads to a decrease in circulating hepcidin, which is elevated in myelofibrosis and contributes to anaemia.

The Survey

The Blood Cancer Survey was an online survey of 1,524 Canadians aged 18 and over, conducted in September 2024 and funded by GSK.
Data were collated from two questions covering awareness and understanding of anaemia and the symptoms of blood cancer with all participants agreeing to participate in full transparency on both the source of the data commissioning, and to the use of their anonymized data.

About the Company : GSK

GSK is committed to maximising patient survival through transformational medicines, with a current focus on breakthroughs in immuno-oncology and tumour-cell targeting therapies, and development in haematologic malignancies, gynaecologic cancers and other solid tumours.