• 01 Oct 2025
• Admin
• News Article

Novartis’ Rhapsido® (remibrutinib) Receives FDA Approval for Chronic Spontaneous Urticaria

Novartis announced today that the US Food and Drug Administration (FDA) has approved Rhapsido® (remibrutinib) as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine therapy. Rhapsido is the first FDA-approved Bruton's tyrosine kinase inhibitor (BTKi) for CSU, offering a novel mechanism of action by inhibiting the release of histamine and other proinflammatory mediators.

Key Highlights

• Rapid symptom relief: Well-controlled disease observed as early as two weeks.
• Oral administration: Taken twice daily with no injections or lab monitoring required.
• Target population: Approximately 1.7 million people in the US live with CSU, with over half remaining symptomatic despite increasing doses of antihistamines.

Mechanism of Action

CSU is a mast cell-driven condition caused by immune dysregulation. BTK activation in mast cells and basophils leads to the release of histamine and other inflammatory mediators, resulting in the characteristic red, itchy, and swollen hives. Rhapsido targets BTK to block this pathway, providing a unique, disease-modifying approach.

Clinical Data

The FDA approval is supported by Phase III REMIX-1 and REMIX-2 trials, which showed:

• Superiority over placebo in itch (ISS7), hives (HSS7), and weekly urticaria activity (UAS7) at Week 12.
• Early disease control: About one-third of patients achieved complete absence of itch and hives at Week 12.
• Safety profile: Most common adverse events included nasal congestion, sore throat, runny nose, bleeding, headache, nausea, and abdominal pain. No lab monitoring is required.

Expanding Novartis Immunology Portfolio

Remibrutinib is also in clinical development for:

• Chronic inducible urticaria (CIndU)
• Food allergy
• Hidradenitis suppurativa (HS)

Novartis has submitted Rhapsido for approval in multiple regions, including the European Union, Japan, and China, with priority review granted in China.

Expert Perspectives

• Mark Lebwohl, MD: “Remibrutinib represents a new way of treating CSU… it stops a key pathway of the immune response in CSU and can provide fast relief.”
• Giselle Mosnaim, MD: “This oral option expands beyond existing injectables and can easily be incorporated into daily life.”
• Lynda Mitchell, CEO of Allergy & Asthma Network: “This therapy empowers patients to manage CSU in a convenient and effective way.”

About Rhapsido® (remibrutinib)

Rhapsido is a prescription medicine for adults with CSU not controlled by antihistamines. It is not approved for other forms of hives and its safety in children is unknown. Patients should consult their healthcare provider about bleeding risks, surgery, liver issues, pregnancy, breastfeeding, and interactions with other medications.

About Novartis

Novartis is an innovative medicines company dedicated to reimagining medicine to improve and extend lives. Its medicines reach nearly 300 million people worldwide.