Key Points :
FDA Clearance: Novartis' oral drug Rhapsido is approved to treat unresponsive patients of chronic spontaneous urticaria with.
Clinical Benefit: Trials revealed greater itch intensity, lower number of hives, and full symptomatic relief in one-third of patients at week 12.
Easy Safety Profile: No monitoring with laboratories is required, which makes it simpler to dispense and adhere to for patients.
Key Background :
Chronic spontaneous urticaria (CSU) is an intermittent hives and swelling condition recurring over more than six weeks with no clear cause. CSU disrupts patients' activities of daily living and induces distress, sleep interference, and anxiety. Conventional treatment with antihistamines and corticosteroids is not completely effective and thereby the quest for newer drugs.
Rhapsido (remibrutinib) was developed to fill the void. The drug inhibits Bruton's tyrosine kinase (BTK), a protein that plays a role in regulating allergic immune response. Inhibiting BTK, the drug reduces excessive immune activity responsible for hives and itching in CSU.
Clinical efficacy and safety were robust in Rhapsido clinical trials. Major improvements in itch severity, hive count, and total disease activity were achieved by all patients treated with a very high percentage of patients achieving complete relief within 12 weeks. The drug has a good safety profile, with no pre-treatment laboratory monitoring necessary before use, making it easy and compliant.
Beyond CSU, Novartis is advancing Rhapsido to treat additional immune diseases, including hidradenitis suppurativa and food allergy. EU and Japanese regulatory submissions, and priority review in China, mark the company's plans to market it worldwide.
The go-ahead is a reflection of a broader trend in drug discovery, one that is concentrating on treatments for disease mechanisms rather than symptom control. Rhapsodo is a significant step for those patients with very few other options and bears witness to the requirement for continued innovation in immunology.
Together, Rhapsodo is a novel, innovative treatment solution for CSU patients and demonstrates Novartis' commitment to curing hard-to-treat, chronic diseases through precision medicine.
About the Author
Kevin Smith
Kevin Smith is a Managing Editor at World Care Magazine.