Core Insights - Novartis announced FDA approval for Rhapsido® (remibrutinib) as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment, marking it as the first FDA-approved Bruton's tyrosine kinase inhibitor (BTKi) for CSU [2][4][6] Group 1: Product Overview - Rhapsido is administered as a pill taken twice daily, offering a non-injection alternative that does not require lab monitoring [2][5] - The drug works by inhibiting the release of histamine and other proinflammatory mediators through targeting BTK, providing a novel approach to CSU treatment [2][4] - Clinical trials (REMIX-1 and REMIX-2) demonstrated that Rhapsido significantly improved symptoms such as itch and hives compared to placebo, with one-third of patients achieving complete absence of symptoms by Week 12 [3][5] Group 2: Market Context - Approximately 1.7 million people in the US suffer from CSU, with over half remaining symptomatic despite higher doses of antihistamines [4][5] - Current treatment options include antihistamines and injectable treatments, but less than 20% of eligible patients receive the latter [2][4] - The approval of Rhapsido is seen as a significant advancement in CSU care, providing patients with a convenient oral option that can be easily integrated into their daily routines [2][6] Group 3: Future Developments - Novartis is also exploring remibrutinib for other conditions such as chronic inducible urticaria, food allergy, and hidradenitis suppurativa, indicating a broader strategy to expand its immunology portfolio [4][6] - The company is committed to investing in innovative therapies aimed at improving care for immune-related conditions [6]