Novartis Secures EU CHMP Positive Opinion for Remibrutinib After Phase III CSU Success
Novartis won a positive CHMP opinion recommending EU marketing authorization for remibrutinib as an oral treatment in adult CSU patients unresponsive to H1 antihistamines. Phase III REMIX-1 and REMIX-2 trials showed symptom improvements by Week 1 sustained to Week 52 with a favorable safety profile.
1. Positive CHMP Opinion Recommendation
The CHMP has adopted a positive opinion recommending marketing authorization for remibrutinib in adult CSU patients who have shown inadequate response to H1 antihistamine treatment. This endorsement marks a key regulatory milestone ahead of the European Commission’s final decision, expected within approximately two months.
2. Phase III REMIX Trial Outcomes
Remibrutinib demonstrated rapid symptom relief in the pivotal REMIX-1 and REMIX-2 trials, with itch and hives improvements observed by Week 1 and sustained through Week 52. The oral BTK inhibitor showed a favorable safety profile, including no liver safety concerns across both studies.
3. Next Steps and Market Potential
Following CHMP recommendation, Novartis will seek European Commission approval to launch remibrutinib for CSU in Europe. The treatment addresses a substantial unmet need, potentially capturing significant share of the adult CSU market and boosting Novartis’s growth in immunology.