The FDA on Wednesday cleared Rhapsido (remibrutinib) as the first treatment specifically approved for symptomatic dermographism (SD), Novartis announced, extending the oral BTK inhibitor's reach into a second major form of chronic hives.

With the new nod, Rhapsido now stands alone as the only chronic hives therapy approved in both chronic spontaneous urticaria (CSU) — its initial indication, won in September 2024 — and SD when H1 antihistamines alone fail patients. CSU and SD together account for more than 90% of chronic hives cases in adults, according to the company's Oct. 7 release.

How did Rhapsido perform against placebo in SD?

The FDA reviewed data from the SD cohort of Novartis' late-stage RemIND trial, which enrolled patients who remained symptomatic on second-generation H1 antihistamines. On a clinical measure of dermographism severity, 29.3% of Rhapsido-treated patients reached a complete response from hives versus 14% on placebo. Novartis reported a "consistent safety profile" in SD and CSU at up to 24 weeks.

What makes SD distinct from CSU?

Unlike spontaneous urticaria, in which itch arises without a clear external trigger, SD belongs to the chronic inducible urticaria category. Pressure, sunlight, friction, heat, cold, or water can set off the wheals. Standard care has long relied on H1 antihistamine updosing, with omalizumab and cyclosporine reserved for refractory cases — a treatment ladder that Rhapsido's oral, targeted mechanism is now designed to short-circuit.

Rhapsido works by inhibiting Bruton's tyrosine kinase, a node in the signaling cascade that drives mast cell degranulation and the histamine release that produces wheals, as well as B-cell-mediated autoantibody production.

Where does Rhapsido fit in the wider chronic hives field?

Rhapsido's first FDA nod made it only the second BTK inhibitor approved in a non-cancer indication, opening the immunology door for the drug class. Novartis has partnered with Roche on Xolair (omalizumab) in U.S. chronic hives care for more than a decade. The European Commission cleared Rhapsido for CSU in April. Sanofi and Regeneron's Dupixent (dupilumab) picked up a CSU label last April for patients whose symptoms persist on antihistamines.

What's next for the remibrutinib program?

Novartis is evaluating Rhapsido in additional inducible urticaria subtypes, including cold urticaria and cholinergic urticaria. Topline data from those cohorts first emerged in February.

"Today's approval marks an important milestone for people living with SD and builds on the first FDA-approved indication for Rhapsido in CSU just over a year ago," said Victor Bultó, Novartis' U.S. president, in a statement. "With Rhapsido now approved for the two most common forms of chronic hives, more people may have the opportunity to find relief from persistent itch, regain confidence in their daily lives, and focus less on their symptoms and more on the moments that matter."

The Oct. 7 decision positions remibrutinib as the only oral, targeted therapy cleared for both ends of the chronic hives spectrum — a base Novartis will look to extend as it pushes into the remaining inducible subtypes.