- Roxadustat is the first in a new class of orally administered hypoxia inducible factor prolyl hydroxylase (HIF PH) inhibitors licensed and reimbursed in Ireland
- The 2019 Nobel Prize in Physiology or Medicine winning discovery of how cells can sense and adapt to changing oxygen availability has enabled the research and clinical development of the HIF-PH inhibitor class1
- The prevalence of CKD in Ireland is approximately 225,000 people2
- According to The World Health Organisation (WHO), 20% of people living with CKD suffer from anaemia3,4
- The condition can impact a patient’s day-to-day living, self-care and mobility5
Astellas Pharma Company Ltd. (part of the Astellas Pharma Inc group TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) is pleased to announce that EVRENZO™ (roxadustat) has been granted reimbursement, in line with its marketing authorisation under the High Tech Drugs Scheme in Ireland from 1st September, 2022, as an option for treating adult patients with symptomatic anaemia associated with CKD.
Roxadustat is the first and only HIF-PH inhibitor licensed and reimbursed for use in Ireland. The licence was based on results from a comprehensive pivotal Phase 3 programme comprising of eight multicentre and randomised studies, which involved 9,600 patients worldwide.6-11 The results of this programme support roxadustat as efficacious in achieving and maintaining target haemoglobin (Hb) levels (10–12 g/dL) in patients with symptomatic anaemia of CKD regardless of dialysis status and irrespective of prior erythropoiesis-stimulating agent (ESA) treatment.6-10 The safety profile observed in the roxadustat development programme is reflective of the CKD populations studied and comparable to ESAs.6-11
‘This is an excellent demonstration of how a ground-breaking, Nobel Prize winning, scientific discovery can inform and pave the way for innovative medicines that can benefit patients.’ said Dr. Timir Patel, Medical Director, Astellas UK and Ireland. ‘Through its novel mechanism of action, roxadustat offers physicians an orally administered option to tackle anaemia of CKD, a complex and multi-faceted disease that can be hugely debilitating.’
Roxadustat activates the body’s natural response to reduced oxygen levels in the blood via inhibition of the HIF-PH pathway. The response involves the regulation of multiple, coordinated processes that improve iron absorption and mobilisation, and increase red cell production, and can therefore assist in the management of anaemia of CKD.
According to The WHO, around 20% of people living with diagnosed CKD suffer from anaemia.3,4 Anaemia of CKD symptoms include dizziness, fatigue and headaches, and can be associated with significant impairment in quality of life.12-15 Additionally, patients with CKD that also suffer from anaemia have impaired health-related quality of life compared to patients without the added complication of anaemia.5
‘Chronic kidney disease patients suffer frequently from anaemia and this complication of CKD has greater impact as CKD worsens. Anaemia significantly impacts patient’s quality of life and vitality’, said Prof. Donal Reddan, Consultant Nephrologist, Galway University Hospital.
‘This licence enhances patient care by providing a novel alternative option for managing anaemia and improving patient’s quality of life’.
About CKD and Anaemia of CKD
CKD is a progressive disease characterised by gradual loss of kidney function that may eventually lead to kidney failure or end stage renal disease, requiring dialysis or kidney transplant.16 Many patients with CKD die of cardiovascular complications before progressing to kidney failure and as such the prevalence of early kidney disease is much greater than end stage disease.16 ,17 CKD impacts one in 10 people globally and is predicted to become the fifth most common cause of premature death globally by 2040.3, 18
Anaemia, a serious medical condition, in which patients have insufficient red blood cells and low levels of haemoglobin, is a common early complication of CKD affecting approximately 20% of CKD patients.4, 15 Anaemia of CKD is associated with an increased risk of hospitalisation, cardiovascular complications and death, and can also cause significant fatigue, cognitive dysfunction and reduced quality of life.5,12 Blood transfusions are used for treating severe anaemia, however, they may reduce a patient’s opportunity for kidney transplant and can increase the risk of infection and/or complications such as heart failure and allergic reactions.19, 20
About Roxadustat
Roxadustat, an oral medicine, is the first in a new class of medicines, HIF-PH inhibitors, that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin; improved iron absorption and mobilisation; and downregulation of hepcidin. Roxadustat is also in Phase 3 clinical development for anaemia associated with myelodysplastic syndromes (MDS) and Phase 2 for chemotherapy-induced anaemia (CIA).
Roxadustat is approved in the United Kingdom, EU member states, including the EEA countries, as well as in Japan, China, Chile South Korea and South Africa for the treatment of anaemia associated with CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe and are currently in review.
Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anaemia associated with CKD in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anaemia associated with CKD in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.
Important Safety Information
The full Summary of Product Characteristics for roxadustat is available at: www.medicines.ie
About Astellas
Astellas Pharma Inc., is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.
Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs, and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets and (vi) infringements of Astellas’ intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement or medical advice
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