Novartis' Rhapsido Approved for CSU: New Oral Treatment Option
Novartis' Rhapsido has been approved by the FDA for treating chronic spontaneous urticaria (CSU), offering a new oral treatment option for adults who still experience hives symptoms despite antihistamine treatment. Rhapsido is the first oral and targeted BTK inhibitor for CSU.
Before Rhapsido, patients who didn't respond completely to antihistamines were often given injectable therapies like Xolair or Dupixent. Rhapsido's mechanism disrupts histamine secretion, preventing itching and swelling typical of CSU. Phase III data showed significant improvements in urticaria activity scores versus placebo, sustained for 24 weeks.
Rhapsido will have a wholesale acquisition cost of $4,521 per 30-day supply and will be available in the coming days. It is expected to be easier to incorporate into patients' daily lives due to its oral formulation. Novartis is also exploring remibrutinib's potential in other immune indications, such as chronic inducible urticaria, acne inversa, food allergies, and multiple sclerosis.
Rhapsido's approval provides a new oral treatment option for adult CSU patients who still experience hives symptoms after antihistamine treatment. Its effectiveness and convenience may improve patients' quality of life, and further studies may expand its potential uses.
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