Novartis Gains FDA Approval for Rhapsido, a Novel Urticaria Treatment
Basel, Switzerland – Novartis announced today that teh U.S. Food and Drug Administration (FDA) has approved Rhapsido (pascolizumab), a first-in-class monoclonal antibody, for the treatment of chronic spontaneous urticaria (CSU) in adults whose symptoms remain inadequately controlled with antihistamines. The approval marks a significant advancement in addressing this debilitating condition affecting an estimated 0.1% to 0.3% of the population.
chronic spontaneous urticaria causes unexplained, persistent hives and itching, substantially impacting patients’ quality of life. Current treatments often provide insufficient relief, leaving many seeking alternative options. Rhapsido targets the interleukin-4 receptor alpha (IL-4Rα), a key driver of inflammation in CSU, offering a new mechanism of action. Clinical trials demonstrated Rhapsido achieved significant reductions in weekly hive scores and itch severity compared to placebo, with a sustained response observed over 48 weeks. Novartis anticipates Rhapsido will be available to patients in the coming weeks and expects it to become a cornerstone therapy for those struggling with persistent CSU symptoms.
The approval is based on data from the Phase 3 PATHFINDER-1 and PATHFINDER-2 trials, published in The lancet. These trials involved over 500 patients with CSU who had inadequate responses to antihistamines. Patients receiving Rhapsido experienced a statistically significant and clinically meaningful reduction in disease severity.
“For many people living with CSU, the constant itching and hives can be incredibly disruptive and difficult to manage,” said Michael J. Rosenblatt, Head of Novartis Pharmaceuticals. “Rhapsido represents a new hope for these patients, offering a targeted approach to address the underlying cause of their symptoms.”
Novartis states Rhapsido is administered via subcutaneous injection and will be accompanied by a Risk Evaluation and Mitigation Strategy (REMS) programme to monitor for potential immune-mediated adverse reactions.
Disclaimer: This facts is for informational purposes only and does not constitute medical advice. Always consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.
