The U.S. Food and Drug Administration (FDA) has granted approval to GSK's Jesduvroq (roxadustat) for the treatment of anemia in adult patients with chronic kidney disease (CKD) who are currently on dialysis. This decision, announced on February 1, 2023, provides a new oral therapeutic option for a patient population with significant unmet medical needs.
The approval is specifically for patients with dialysis-dependent CKD, which narrows the potential market reach of the drug compared to an approval for all CKD patients with anemia. Anemia is a common and serious complication of CKD, often requiring treatment with erythropoiesis-stimulating agents (ESAs) and/or iron supplementation. Jesduvroq offers an alternative approach by stimulating erythropoiesis through a different mechanism.
Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). It works by stabilizing HIF, a transcription factor that regulates the expression of genes involved in erythropoiesis, iron metabolism, and angiogenesis. By increasing HIF levels, roxadustat stimulates the production of red blood cells, improving hemoglobin levels in patients with anemia.
The clinical development program supporting the approval included multiple Phase 3 trials evaluating the efficacy and safety of roxadustat in dialysis-dependent CKD patients. These trials demonstrated that roxadustat was effective in increasing and maintaining hemoglobin levels within the target range, reducing or eliminating the need for ESAs and iron supplementation in some patients. The most common adverse reactions reported in clinical trials included hypertension, vascular access complications, and diarrhea.
The current standard of care for anemia in CKD often involves injectable ESAs, which can be associated with cardiovascular risks and require frequent monitoring. Oral therapies like Jesduvroq offer a more convenient administration route and may reduce the burden on patients and healthcare providers. However, the long-term safety and efficacy of roxadustat compared to ESAs will require further evaluation in real-world settings.
Following the FDA's announcement, GSK shares experienced a modest increase of 1.2% in London trading, indicating a positive, albeit measured, market response to the regulatory decision.
