FDA Approves First Oral Targeted BTKi Treatment for Patients with Chronic Hives

The FDA approved remibrutinib (Rhapsido; Novartis AG) as a treatment for chronic spontaneous urticaria (CSU; chronic hives) on Tuesday, according to a press release from Novartis.¹

The approval marks hope for tens of thousands of patients who remain symptomatic despite standard antihistamine treatments, and is especially noteworthy as it is the first oral Bruton tyrosine kinase inhibitor (BTKi) to treat CSU.¹

Why Is This Treatment Needed?

Urticaria is one of the most common dermatological diseases. Usually symptoms subside within 24 hours, but for chronic sufferers, the disease can last for more than 6 weeks and can recur again for 1 to 5 years, or longer for patients with severe cases. Researchers in the US found that about 20% of people will experience urticaria at some point, though a 2010 article found little data on the prevalence of CSU.² However, since patients tend to be between the ages of 20 and 40 and are known to see their work, mental health, personal lives, and sleep impacted by the condition, they represent an urgent unmet medical need. The economic and health care impact is also not quantified by extant studies.

CSU is also one of the most mysterious of dermatological conditions, since the exact cause is unknown and often patients present the condition without identifiable triggers. While antihistamines are the standard treatment, "over half of patients still have symptoms, even at higher doses," according to the Novartis press release.^1-2 Injectable biologic therapies, including omalizumab (Xolair; Genentech, Novartis), are available for patients who do not respond to antihistamines, but less than 20% of eligible patients take them.⁴

What Is the Clinical Trial Evidence for Remibrutinib?

The approval is based on 2 phase 3 studies, REMIX-1 (NCT05030311) and REMIX-2 (NCT05032157), which recruited patients with CSU that persisted despite treatment with antihistamines. Patients were randomized to receive 25 mg of remibrutinib twice per day or a placebo.

Results of the trials showed that patients on remibrutinib achieved well-controlled disease as early as Week 2. By Week 12, patients on remibrutinib reported significant improvement in itch, hives, and urticaria activity. About one-third of patients reported a complete absence of itching and hives within that time.¹

The trials also showed a manageable safety profile, with about 3% of patients reporting adverse events such as nasal congestion, sore throat, runny nose, bleeding, headache, nausea, and abdominal pain.

What Is the Potential Impact of Remibrutinib?

As the first oral medication for CSU, remibrutinib represents a chance for patients to get relief for CSU quickly and easily. Victor Bultó, president of Novartis' US unit, said, "This approval of Rhapsido as the first and only BTK inhibitor in CSU is an important milestone in our journey to reshape care for overlooked immune-related conditions and offer more patients the potential to find fast relief.”¹

Novartis is also conducting ongoing trials of remibrutinib as a treatment for chronic inducible urticaria (CIndU), hidradenitis suppurativa (HS), and food allergy. Its ease of administration in these indications versus existing injectable therapies could multiply remibrutinib's positive impact on patients' lives.

Pharmacists play a crucial role in identifying patients who may benefit from remibrutinib as a treatment for CSU, especially patients who are not currently treated by injectable therapies. By collaborating with healthcare providers, educating patients, and monitoring adherence and potential side effects, pharmacists can reduce the number of patients with CSU who currently live without any effective treatment.

REFERENCES

1. Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU). News release. Novartis. September 30, 2025. Accessed Sept. 30, 2025. https://www.globenewswire.com/news-release/2025/09/30/3159065/0/en/Novartis-receives-FDA-approval-for-Rhapsido-remibrutinib-the-only-oral-targeted-BTKi-treatment-for-chronic-spontaneous-urticaria-CSU.html

2. Maurer M, Weller K, Bindslev‑Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria: A GA²LEN task force report. Allergy. 2011;66(3):317‑330. doi:10.1111/j.1398-9995.2010.02496.x. Accessed Sept. 30, 2025.

3. Dabija D, Tadi P, Danosos GN. Chronic Urticaria. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan‑. Updated April 17, 2023. Bookshelf NBK555910.

4. Maurer M, Raap U, Staubach P, et al. Antihistamine-resistant chronic spontaneous urticaria: 1-year data from the AWARE study. Clin Exp Allergy.2019; 49: 655–662. https://doi.org/10.1111/cea.13309