Novartis (NVS) announced on Monday that the European Commission has approved Rhapsido (remibrutinib) for chronic spontaneous urticaria (CSU) in adult patients with an inadequate response to H1-antihistamine treatment.
Notably, on September 30, 2025, the FDA approved Rhapsido for chronic spontaneous urticaria, making it the first Bruton's tyrosine kinase inhibitor approved for CSU.
CSU is a chronic skin condition affecting approximately 40 million people worldwide, impacting nearly twice as many women as men and occurring most frequently between the ages of 20 and 40 years.
Remibrutinib is an oral BTK inhibitor that blocks the BTK pathway involved in histamine release, a key driver of itchy hives and swelling.
In the Phase 3 REMIX 1 & 2 studies, comprising 925 patients who remained symptomatic on second-generation H1-antihistamines, Rhapsido demonstrated superiority over placebo in change from baseline in itch, hives, and weekly urticaria activity at Week 12, with a favourable safety profile and no liver safety concerns.
Earlier in February 2026, Rhapsido received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Rhapsido, in addition to CSU, is also developed for conditions such as chronic inducible urticaria, food allergy, and hidradenitis suppurativa.
NVS has traded between $104.93 and $170.46 over the last year. The stock closed Friday's trade at $145.47, down 1.36%.
In the pre-market, NVS is down 0.81% at $144.25.
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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.