A little over a year after landing its flagship approval in chronic hives, Novartis’ oral BTK inhibitor Rhapsido is expanding its reach with a new FDA nod that comes with a notable ‘first’ for the field.
On Wednesday, Novartis announced that U.S. regulators have cleared the way for Rhapsido (remibrutinib) as an inaugural treatment for patients with symptomatic dermographism (SD) that isn’t properly kept under control with H1 antihistamines.
Chronic spontaneous urticaria (CSU)—where Rhapsido won its first green light last fall—and SD are among the most prevalent manifestations of chronic hives, collectively cropping up in more than 90% of adults who live with the condition, Novartis said in an Oct. 7 release.
Unlike spontaneous urticaria, in which itchiness occurs without a clear external trigger, SD falls into the category of chronic inducible urticaria, which can be set off by triggers to the skin like pressure, sunlight, friction, heat, cold or water.
With the expansion, Rhapsido now stands alone as the only chronic hives treatment approved in both CSU and SD when antihistamines alone aren’t adequate for patients, Novartis said.
The FDA cleared the new indication after reviewing data from the SD cohort in Novartis’ late-stage RemIND trial, which specifically looked at patients who remained symptomatic on second-generation H1 antihistamines. The data showed that patients on Rhapsido hit higher rates (29.3%) of complete response from hives versus placebo (14%) on a clinical measure of the severity of dermographism symptoms.
Novartis had first revealed a topline win for Rhapsido in SD and several other subtypes of inducible urticaria back in February.
In its approval announcement, Novartis added Rhapsido demonstrated a “consistent safety profile” in SD and CSU at up to 24 weeks in its study.
“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,” he said, “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.”
With Novartis’ first Rhapsido approval last September, the company picked up the FDA’s second nod for a BTK inhibitor in a non-cancer indication. Chronic hives is hardly unfamiliar territory for the Swiss drugmaker, which has been partnered with Roche on Xolair for the immune condition in the U.S. for over a decade.
Rhapsido’s novel mechanism of action, meanwhile, focuses on the role BTK plays in mast cell degranulation, which tees up the histamine release that triggers hives, as well as its ability to target B cell-mediated autoantibody production.
Apart from SD and CSU, the company is also assessing Rhapsido in additional forms of inducible urticaria, including cold urticaria and cholinergic urticaria. Meanwhile, the drug scored a European Commission nod in CSU back in April.
As for another recent entrant into the chronic hives space, Sanofi and Regeneron last April picked up a CSU indication for their mega-blockbuster Dupixent, overcoming a rejection in the condition back in 2023.
That approval also specifically covers patients whose chronic hives symptoms remain despite use of antihistamines. the