Novartis’ marketed therapy, Rhapsido (remibrutinib), has been shown to offer rapid and durable impacts on various subtypes of chronic induced urticaria (CIndU) in a late-stage study – potentially setting the drug on track for a label expansion.
The drug posted a win in the Phase III RemIND study (NCT05976243), which is looking into Rhapsido’s potential in treating the three most common subtypes of the rare skin disease. This includes symptomatic dermographism (SD), for which the drug is already approved in the US, as well as cold and cholinergic urticaria.
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Through a long-term analysis of RemIND, researchers found that patients who were initially randomised to receive Rhapsido experienced sustained symptom improvements throughout the 52-week treatment period across all three subgroups.
At week 2, within the SD population, 41.8% of Rhapsido-treated patients experienced a complete or partial response compared to 19.2% in the placebo arm at one week, while 67.4% responded versus 28.9% in the cold urticaria group at the same timepoint. Meanwhile, 65.2% of patients with cholinergic urticaria experienced some degree of response to Rhapsido at week two, over 45.6% in the placebo arm.
At week 52, complete or partial response rates were 46.8%, 83.3% and 58.2% in patients initially randomised to Rhapsido and 47.7%, 88.9% and 69.8% in patients who switched from placebo to Rhapsido at week 24 in the SD, ColdU and CholU cohorts, respectively.
The response rates were also largely comparable between patients who had first been randomised to placebo and then switched to Rhapsido versus patients who received the drug from the start of the study.
Researchers found that the Bruton’s tyrosine kinase (BTK) inhibitor was generally well tolerated across the CIndU patient population, as no new safety signals were observed in this study.
With these positive results in the bag, Novartis is planning to file additional regulatory submissions for Rhapsido in CIndU, which could notably expand the drug’s addressable patient population to include cold and cholinergic urticaria, which impact around 0.05% and 0.02-0.03% of the global population, respectively. Currently, Rhapsido is approved in the US, EU, China and Japan for the treatment of chronic spontaneous urticaria (CSU), while it holds authorisation for use in SD within the US.
CindU is not the only indication that Novartis is eyeing for Rhapsido, however, as the Swiss pharma giant is also looking to expand the drug’s use to immune-mediated diseases such as hidradenitis suppurativa (HS), food allergy, multiple sclerosis (MS), papulopustular rosacea and chronic itch.
According to analysts at GlobalData, Rhapsido will soon become a blockbuster seller for Novartis, with the drug expected to approach the $5bn sales mark in 2032. Rhapsido’s strong market performance would be welcome for Novartis, as some investors critique the company’s M&A approach amid multiple high-profile study failures.
