Novartis announces FDA approval of Rhapsido for symptomatic dermographism

The FDA approved Novartis' drug remibrutinib (Rhapsido) for treating symptomatic dermographism in adults unresponsive to H1 antihistamines. In a Phase III trial, 29.3% of patients saw complete hive resolution after 12 weeks, compared to 14% on placebo. Novartis states this is the first approved treatment specifically for this condition.

The FDA approved Novartis' remibrutinib (Rhapsido) on October 7, 2026, as the first treatment for adults with symptomatic dermographism (SD) not controlled by H1 antihistamines. The drug, an oral BTK inhibitor, also treats chronic spontaneous urticaria (CSU). The approval was based on phase 3 trial data showing higher complete response rates from hives compared to placebo. Novartis plans further submissions for other immune-mediated conditions.

Novartis (NYSE: NVS) received FDA approval for Rhapsido to treat symptomatic dermographism (SD). The drug is the first approved for SD and also treats chronic spontaneous urticaria (CSU). Clinical trials showed 29.3% of patients achieved complete hive clearance. NVS shares rose 1.91% to $143.47. The company is also studying remibrutinib for other conditions.

Novartis will present 46 abstracts at MSToronto2026, including Phase III REMODEL-1/-2 results for remibrutinib and new Kesimpta data in pediatric MS. Additional Kesimpta research covers pregnancy outcomes and comparisons with first-line treatments. Novartis will host an investor call post-presentation to discuss remibrutinib's potential in MS.

FDA expanded approval of Novartis' Rhapsido (remibrutinib) to treat symptomatic dermographism, a skin condition causing chronic hives. The approval follows positive phase 3 trial results showing significant symptom reduction. Rhapsido was previously approved for chronic spontaneous urticaria. According to Novartis, this marks an important milestone for treating chronic hives.

The US FDA expanded approval of Novartis' drug remibrutinib (Rhapsido) to treat adults with symptomatic dermographism, a chronic skin condition. The drug is now approved for two forms of chronic hives. In trials, 29.3% of patients saw complete resolution of hives after 12 weeks, versus 14% on placebo. Novartis reports improvements as early as two weeks. The drug's safety profile was consistent with earlier studies.