The first oral BTK blocker for chronic spontaneous urticaria, Rhapsido offers a more convenient treatment option for patients who still show symptoms after antihistamine treatment.
The FDA has approved Novartis’ remibrutinib for the treatment of chronic spontaneous urticaria. The drug will be marketed under the brand name Rhapsido.
In particular, Rhapsido is indicated for adult patients who continue to suffer from the symptoms of hives even after antihistamine treatment. In the U.S., that means a market of more than half of the 1.7 million people with the condition, according to a company press release on Wednesday. Rhapsido will have a wholesale acquisition cost of $4,521 per 30-day supply, and will be available “in the coming days,” a Novartis spokesperson told BioSpace in an email.
Rhapsido is the first oral and targeted BTK inhibitor for chronic spontaneous urticaria (CSU). Before its approval, patients who do not respond completely to antihistamines were given injectable therapies, such as Roche’s Xolair. In April this year, the FDA expanded treatment options for CSU when it approved Sanofi and Regeneron’s Dupixent for the indication.
Unlike Xolair and Dupixent, which are monoclonal antibodies, Rhapsido is an orally available blocker of the BTK enzyme. This mechanism disrupts a signaling cascade and prevents the secretion of histamine, which causes the itching and swelling typical of CSU. Phase III data from the REMIX program, published in March in the New England Journal of Medicine, showed treatment with Rhapsido resulted in improvements in urticaria activity scores versus placebo, a benefit that was sustained through 24 weeks of follow-up.
In a prepared statement alongside Novartis’ press announcement on Tuesday, Giselle Mosnaim, University of Chicago immunologist and investigator on the REMIX trial, called Rhapsido’s approval “significant,” noting that it provides an alternative “beyond existing injectable treatments and gives patients an oral option that can easily be incorporated into their daily lives.”
Besides CSU, Novartis is also testing remibrutinib—Rhapsido’s active ingredient—in other immune indications. In March last year, the pharma reported findings from a small Phase IIb study, demonstrating that a 25-mg dose of the drug achieved a 50% reduction in abscesses and inflammatory nodules in 73% of treated patients with hidradenitis suppurativa, compared with 34.7% of placebo comparators.
At the time of that mid-stage readout, Novartis said it had plans to file for approval in this indication before the end of 2024, but it is unclear if the company pushed through with those plans. In its latest earnings presentation, remibrutinib’s hidradenitis suppurativa program was listed as a late-stage project.
Beyond immunology, Novartis is also testing remibrutinib as a therapy for multiple sclerosis, for which it is running two Phase III studies. Primary completion for both trials is expected in 2026.
