- Jakavi is the first JAK1/2 inhibitor available in Australia for the treatment of patients aged 12 years and older with acute or chronic graft versus host disease (GvHD), who have inadequate response to corticosteroids or other systemic treatments
- Approval is based on the Phase III REACH2 and REACH3 clinical studies which had contributions from local clinical centres 2,3
- Graft-versus-host disease (GvHD) is a serious and debilitating complication of stem cell transplants, with no established standard of care for patients, who do not adequately respond to first-line steroid treatment4-6
WEDNESDAY 12 APRIL 2023, Sydney: Novartis is pleased to announce the listing of oral therapy Jakavi® (ruxolitinib) on the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients aged 12 years and older affected by acute or chronic graft versus host disease (GvHD), who have inadequate response to corticosteroids or other systemic treatments.1
Graft-versus-host disease (GvHD) is a serious and debilitating complication of stem cell transplants, with no established standard of care for patients, who do not adequately respond to first-line steroid treatment.4-6 Nearly half of patients, who undergo allogeneic transplants experience either acute or chronic GvHD, or both.4-6
"An allogeneic transplant is a lifesaving treatment for many patients with blood disorders including cancers. However, graft versus host disease (GVHD), is a challenging complication that has profound impacts on patients' quality-of-life and can have fatal consequences. The standard approach is to use high dose steroids which can have serious side effects especially if used long term. Many patients either don't respond to steroids or are unable to tolerate them for extended periods of time. It is exciting that we now have a new standard of care to offer these patients. Patients living with graft versus host disease are survivors of a long and complicated diagnosis and treatment journey. It is a privilege to be able to offer them this advancement in GVHD treatment," Associate Professor Hamad said.
Jakavi is the first JAK1/2 inhibitor available in Australia for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease (GvHD) who have inadequate response to corticosteroids or other systemic treatments.1 To date, over 300 patients in Australia have accessed JAKAVI for the treatment of GvHD through clinical trials or access programs.
"As someone who lost their partner to GvHD, I have seen just how devastating this disease can be. I cannot express how grateful I am to have new medications such as Jakavi to treat people who have had a donor stem cell transplant. GvHD is an incredibly common side effect, affecting over 50% of all transplant patients where donor stem cells are used, so to read such positive stories from patients about their quality of life after being treated with Jakavi is something which gives hope to so many," said Neil Pennock, Founding Director, TLR Foundation.
"Time is of the essence for patients living with acute and chronic Graft versus Host disease (GvHD) and their caregivers, who have had no other, or limited, treatment options until now. Globally, little progress has been made over the past 30 years in developing a treatment for GvHD. We are excited to be able to bring Jakavi to people living with GvHD in Australia," said Richard Tew, Country President Novartis Australia, and New Zealand.
Please review the full Consumer Medicines Information here: https://www.guildlink.com.au/gc/ws/nv/cmi.cfm?product=nvcjakor11215
About graph-versus-host-disease
Graft-versus-host disease (GVHD) is a complication of allogeneic stem cell transplantation, in which the donor's immune cells attack the patient's own cells, potentially affecting the skin, liver, and gut. GvHD can occur in acute or chronic forms and is the cause of most deaths following transplantation.10 Symptoms of GvHD can appear in the skin, gastrointestinal tract, liver, mouth, eyes, genitals, lungs, and joints.4, 7,11-13It is estimated that approximately half of patients who receive allogeneic stem cell transplants will develop GVHD.5
About Jakavi® (ruxolitinib)
Jakavi® (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. Jakavi is approved by the European Commission for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease- related splenomegaly or symptoms in adult patients with primary myelofibrosis (MF) (also known as chronic idiopathic MF), post-polycythemia vera MF or post-essential thrombocythemia MF, and also for patients aged 12 years and older with acute or chronic GvHD who have inadequate response to corticosteroids or other systemic therapies. Jakavi is approved in over 100 countries for patients with MF, including EU countries, Switzerland, Canada, Japan and in more than 85 countries for patients with PV, including EU countries, Switzerland, Japan and Canada. The exact indication for Jakavi varies by country. Additional worldwide regulatory filings are underway in MF and PV.14
About Novartis
Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world.
