Novartis wins EU green light for Rhapsido in chronic urticaria, opening front in oral immunology drugs
Novartis has secured European Commission approval for Rhapsido, its oral chronic skin disease drug, broadening the geographic reach of one of the Swiss group's most strategically significant immunology launches and opening a new front in the increasingly competitive market for oral targeted therapies.
The Basel-based pharmaceutical group said on Monday that the Commission had cleared Rhapsido, known generically as remibrutinib, for the treatment of adult patients with chronic spontaneous urticaria, or CSU, who have failed to respond adequately to conventional H1-antihistamine therapy. The drug — taken as a 25mg tablet twice daily, with no laboratory monitoring required — is the first oral targeted treatment approved for the condition in Europe, building on a US Food and Drug Administration approval secured in September 2025.
"Rhapsido is the first oral targeted treatment approved for CSU, offering a unique approach to CSU treatment in a pill taken twice daily without any lab monitoring required," the company said in a statement.
The European green light, which followed a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in February, marks a significant step in Novartis's effort to anchor its post-Cosentyx immunology franchise on remibrutinib. The drug is being developed across several immune-mediated indications beyond CSU, including chronic inducible urticaria, food allergy and hidradenitis suppurativa, and Novartis is preparing to begin a phase 3 programme in food allergy in the second half of 2026.
The commercial rationale is significant. CSU affects an estimated 40 million people worldwide and is roughly twice as common in women as in men, with onset typically between the ages of 20 and 40. Existing treatment options have largely been limited to escalating doses of antihistamines and, for the most refractory cases, injectable biologics — leaving an oral, targeted therapy with a clean monitoring profile as a potentially attractive alternative for both patients and prescribers. In the US alone, an estimated 1.7 million people live with CSU, more than half of whom remain symptomatic despite increasing doses of antihistamines.
The approval comes against the backdrop of a wider Novartis push to broaden its immunology portfolio. The group's Cosentyx franchise, marketed for psoriasis, hidradenitis suppurativa and other inflammatory conditions, remains a cornerstone of revenue, but the company has been actively developing remibrutinib alongside other immunology assets to diversify the pipeline ahead of long-term competitive pressures. Regulatory submissions for Rhapsido in CSU are also progressing in Japan, China and other jurisdictions, with priority review granted in China.
The drug's clinical profile rests on data from the phase 3 REMIX-1 and REMIX-2 trials, in which Rhapsido demonstrated superiority over placebo in itch, hives and weekly urticaria activity scores at week 12. Significantly more patients on the drug achieved well-controlled disease as early as week 2, and roughly one-third experienced complete resolution of itch and hives at week 12. The most common adverse events were nasal congestion, sore throat, headache, nausea, abdominal pain and bleeding, with around 9 per cent of patients in trials reporting some form of bleeding event.
For Novartis, the European approval represents both a near-term commercial opportunity and a strategic validation of the broader BTK-inhibitor platform — a class of drugs originally developed for blood cancers but increasingly viewed as a promising therapeutic avenue across allergic and immune-mediated diseases.