Chronic renal failure anemia: Aifa approves new oral therapy
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Fatigue, rapid heartbeat, shortness of breath, loss of appetite, mental confusion, dizziness, headache and depression. These are the main symptoms that characterize a less known and fortunately less widespread type of anemia: that associated with chronic kidney disease, a condition that affects one in 10 people worldwide, one in five of whom suffer from untreated anemia or not targeted and associated with significant impairment in quality of life with possible progression to adverse cardiovascular and renal outcomes. For patients suffering from it, AIFA approved the reimbursement of roxadustat, the first orally administered inhibitor of prolyl-hydroxylase (PH) of hypoxia inducible factor (HIF), a new class of drugs for patients adults with symptomatic anemia associated with chronic kidney disease.
What is anemia of chronic kidney disease
Chronic Kidney Disease is associated with various complications as the function of the kidneys becomes impaired. One of these is precisely anemia which can be caused by several factors, including reduced oxygen detection in the kidneys, reduced production of erythropoietin, chronic inflammation that leads to increased levels of hepcidin and a lack of iron. . “Anemia is a condition characterized by a reduced production of red blood cells which compromises the oxygen supply in the body – declares Luke DeNicola, full professor of Nephrology and Director of the School of Specialization in Nephrology, University of Campania L. Vanvitelli of Naples. “In patients with chronic kidney disease, anemia is one of the most frequent complications, which already occurs in the early stages of the disease, contributing to the progression of cardio-renal damage and the reduced quality of life of the nephropathic patient. Unfortunately, chronic kidney disease is silent and for this reason dramatically underestimated; the impact on the patients’ quality of life is heavy both from a physical and psychological point of view”.
Are you familiar with chronic kidney disease anemia?
by Mara Magistroni
The clinical studies
For these patients there is now a therapy that belongs to a new class of drugs. The Italian Medicines Agency (AIFA) has approved the reimbursement of roxadustat for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD), whether or not they are on dialysis. Roxadustat is the first HIF-PH inhibitor, it is administered orally and increases hemoglobin (Hb) levels through a different mechanism of action than injectable erythropoiesis stimulating agents (ESAs), which are typically administered together with iron intravenously. The approval of the reimbursement by AIFA follows that of the European Commission and the European Medicines Agency based on the results of a phase 3 clinical development program which includes 8 multicentre and randomized clinical trials, involving 9,600 patients in Worldwide. The results of this program support the efficacy of roxadustat in achieving and maintaining target Hb levels (10-12 g/dL) in patients with symptomatic CKD anemia, regardless of whether or not they are on dialysis or have been previously treated with erythropoiesis-stimulating agents.
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Like in the high mountains
But how does this new drug work? Eight studies have clarified this and their names (Alps, Dolomites, Pyrenees, Himalayas, Sierras, Rockies, Andes, Olympus) recall the concept of high mountains associated with the reduction of oxygen and the mechanism of action of the drug. As an HIF-PH inhibitor, roxadustat activates the body’s natural response to reduced blood oxygen levels. This response involves the regulation of multiple coordinated processes leading to correction of anemia with reduced intravenous iron requirement. “Roxadustat works by inhibiting an enzyme called prolyl-hydroxylase (PH), which degrades hypoxia-inducing factor (HIF) – explains Francis Locatelli, former Director of the Department of Nephrology, Dialysis and Kidney Transplantation, Manzoni Hospital in Lecco. “By reversible inhibition of HIF-PH, roxadustat stimulates a coordinated erythropoietic response including elevation of endogenous plasma erythropoietin levels, regulation of iron transport proteins, and reduction of hepcidin, an iron regulatory protein , which is increased during inflammation in CKD. This determines a better bioavailability of iron, an increase in the production of hemoglobin and an increase in the mass of erythrocytes”.
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