Discussing Remibrutinib Following FDA Approval for CSU, With Adam Friedman, MD

Following the US Food and Drug Administration (FDA) approval of remibrutinib for adult patients with chronic spontaneous urticaria (CSU), the HCPLive team spoke with Adam Friedman, MD, on the approval and its significance for patients and clinicians seeking an oral option for CSU.1,2

The approval of remibrutinib, a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, was announced by Novartis following the positive results of the phase 3 REMIX-1 and REMIX-2 studies. Friedman, professor and chair of dermatology at the George Washington University School of Medicine & Health, was asked about these data on remibrutinib and how he sees the medication shifting the landscape of CSU treatment.

“As someone who has been a champion for chronic spontaneous urticaria, the artist formerly known as chronic idiopathic urticaria…I'm really excited about, honestly, any FDA approval for this condition,” Friedman explained. “Because with new approvals, with new options that are hopefully more effective, easier to implement, and that means that we as a specialty have more options to better address these patients.”

Friedman highlighted remibrutinib’s use as a BTK inhibitor, noting that the drug affects patients through the inhibition of the BTK pathway, which prevents histamine release. Consequently, the drug reduces hives and angioedema in patients with CSU and, when implemented with standard-dose antihistamines, can impact both histamine release and histamine receptor activity.

“Now, where it falls in the guidelines, is it going to be on par with [dupilumab and omalizumab], that is TBD, but I think it's really quite amazing that we now will have three options that would be employed very quickly if, after three to four weeks of that, up-dosing of those second generation antihistamines fail,” Friedman said. “Which we see, from the data, is roughly about 50% of these patients. We now will have three options, two injectables, one oral, which means that we can be more personalized to the patient experience.”

The phase 3 findings from REMIX-1 and REMIX-2 had shown that remibrutinib use led to early and substantial reductions in patients’ CSU symptoms. The data also showed disease improvements sustained for up to 52 weeks. Friedman was asked about whether any distinct patient groups may benefit from the drug.

“I think good candidates would truthfully be any patient that has failed the…rapid escalation to fourfold, the recommended dosing of second-generation nonsedating antihistamines,” Friedman explained. “…Now, in terms of patients that we have to think about for whom this wouldn't be appropriate, certainly, until there's data registry data available about pregnancy and lactation, we're going to need to be a little cautious with that. I think there's a more cautious, yet optimistic approach when it comes to any medication.”

Friedman highlighted some existing guidance regarding patients with hepatic insufficiency with respect to concerns of whether someone has some liver impairment. These may be 1 of the only subgroups requiring some minor consideration, though Friedman noted that there is not a lot of current evidence that many patient subpopulations will have any significant concerns.

The quotes contained in this interview summary were edited for the purposes of clarity.

In his financial disclosures, Friedman reported serving as a consultant or advisor for Novartis.

References

1. Novartis Pharma AG. Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU). GlobeNewswire News Room. Published September 30, 2025. Accessed September 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. Novartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria. Novartis. https://www.novartis.com/news/media-releases/novartis-phase-iii-data-confirm-sustained-efficacy-and-long-term-safety-oral-remibrutinib-chronic-spontaneous-urticaria.