Novartis Wins CHMP Nod for Rhapsido EU Approval, Phase III Shows 52-Week Efficacy
Novartis received a positive CHMP opinion recommending marketing authorization for Rhapsido as an oral BTK inhibitor for adult chronic urticaria in the EU, with a European Commission decision due within two months. Phase III REMIX studies showed sustained itch and hive reductions through week 52 with no liver safety concerns.
1. CHMP Positive Opinion
The EMA’s CHMP has issued a positive opinion recommending marketing authorization for Rhapsido as an oral BTK inhibitor in adult chronic spontaneous urticaria patients who have failed second-generation H1 antihistamines, with a final European Commission decision expected within two months.
2. Phase III REMIX Study Results
Data from the late-stage REMIX-1 and REMIX-2 trials demonstrated significant reductions in itch and hives sustained through week 52, alongside quality-of-life improvements and a favorable safety profile without liver signal concerns.
3. Broader Development Plans
Beyond CSU, Rhapsido is in phase III development for chronic inducible urticaria under the RemIND study and is being evaluated in other immune-mediated conditions such as hidradenitis suppurativa and food allergies, expanding Novartis’ immunology franchise.
4. Competitive Context
Regeneron and Sanofi’s Dupixent also received a CHMP positive opinion for extended use in pediatric moderate-to-severe CSU, underlining a competitive landscape and the need for Rhapsido to differentiate on efficacy, safety and convenience.