Core Insights - Novartis announced FDA approval for Rhapsido (remibrutinib) as the first oral treatment for chronic spontaneous urticaria (CSU) in adults who remain symptomatic despite H1 antihistamine treatment [2][5][9] - Rhapsido is a twice-daily pill that targets Bruton's tyrosine kinase (BTK) to inhibit histamine release, providing a new treatment option for CSU patients [2][6][7] Company Developments - The approval is based on Phase III clinical trials (REMIX-1 and REMIX-2), showing Rhapsido's superiority in reducing itch and hives compared to placebo [6][8] - Rhapsido demonstrated a safety profile that does not require lab monitoring, with common adverse events including nasal congestion and headache [8] - Novartis is expanding its immunology portfolio with Rhapsido, which is also in development for other conditions like chronic inducible urticaria and food allergies [7][9] Industry Context - CSU affects approximately 1.7 million people in the US, with over half remaining symptomatic despite antihistamine treatment [7] - The approval of Rhapsido represents a significant advancement in CSU care, offering patients a convenient oral option that can improve their quality of life [5][9] - The treatment landscape for CSU has been limited, with many patients feeling underserved by existing therapies [5][4]