Novartis Receives FDA Approval for Rhapsido: First Oral BTK Inhibitor for Chronic Hives
Novartis' Rhapsido (remibrutinib) received FDA approval as the first oral BTK inhibitor (BTKi) for treatment of adults with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine therapy157.
Rhapsido is a twice-daily oral pill, offering a convenient, injection-free, lab-monitoring-free treatment option for chronic hives14.
The approval was supported by Phase III REMIX-1 and REMIX-2 clinical trials, which showed Rhapsido's superiority over placebo in reducing itch, hives, and overall urticaria activity at Week 12; well-controlled disease was observed as early as two weeks2.
About one-third of patients treated with Rhapsido achieved complete absence of itch and hives at Week 122.
The most common adverse events (≥3%) were nasopharyngitis, bleeding, headache, nausea, and abdominal pain. The safety profile does not require lab monitoring2.
Rhapsido is also being evaluated for other immune-related conditions, including chronic inducible urticaria, food allergy, and hidradenitis suppurativa14.
Novartis has made regulatory submissions for Rhapsido in the EU, Japan, and China, with priority review in China4.
This approval will likely intensify Bruton's tyrosine kinase inhibitor (BTK) competition in immunology, as Novartis is the first to market with an oral targeted therapy for CSU5.
Sources:
1. https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu
2. https://www.pharmaceutical-era.com/press-releases/novartis-receives-fda-approval-for-rhapsido-r-remibrutinib-the-first-oral-targeted-btki-treatment-for-chronic-spontaneous-urticaria-csu
4. https://www.nasdaq.com/articles/fda-approves-novartis-rhapsido-first-btki-oral-therapy-chronic-spontaneous-urticaria
5. https://www.fiercepharma.com/pharma/novartis-kicks-btk-competition-immunology-fda-approval-remibrutinib-chronic-hives