Novartis wins FDA nod for Rhapsido, a first-in-class oral treatment for chronic hives

The FDA approved Novartis’ remibrutinib (brand name Rhapsido) as an oral therapy for adults with chronic spontaneous urticaria (CSU, or chronic hives) who don’t respond to antihistamines.

Why it matters: Rhapsido could reshape treatment for nearly 400,000 U.S. patients with moderate to severe CSU, offering a convenient pill instead of injectables like Xolair or Dupixent. With limited existing options, Novartis is targeting a multibillion-dollar market and positioning itself against Sanofi in the race to expand Bruton’s tyrosine kinase (BTK) inhibitors beyond cancer.

Backstory: CSU is a debilitating immune condition marked by unpredictable itching and hives. Novartis’ Rhapsido, a BTK inhibitor, combats CSU by blocking histamine release and autoantibody production. While both Novartis and Roche have marketed their own drug, Xolair, since 2014, injection delivery and safety warnings have limited its acceptance.

Zoom in: Rhapsido´s safety profile requires no lab monitoring, making it easier for dermatologists to prescribe and showed a lot of promise in clinical trials. In phase 3 trials (Remix-1, Remix-2), Rhapsido significantly reduced hives and itching, with nearly half of patients symptom-free at one year.

Big picture: The approval kicks off competition between Novartis and Sanofi in immunology BTK inhibitors, as Sanofi’s own BTK inhibitor, Wayrilz, recently won approval in immune thrombocytopenia and is advancing in CSU and other immune diseases. Both are pursuing a wide range of immune and allergic diseases, aiming to carve out leadership as biologics like Cosentyx face looming patent cliffs.

What’s next: Novartis plans pivotal readouts in 2026 for other conditions like chronic inducible urticaria and multiple sclerosis, while exploring food allergy, a potential 20M-patient market.