EMA Recommends Dupixent for Paediatric Urticaria; Rilzabrutinib Gains Japanese Orphan Status
The EMA’s CHMP recommended approval of Sanofi and Regeneron’s Dupixent for children aged 2-11 with moderate-to-severe CSU based on Phase III LIBERTY-CUPID trials, with final EU authorization and FDA decision due by April 2026. Additionally, rilzabrutinib earned orphan drug designation in Japan for IgG4-related disease after positive Phase II results.
1. EU CHMP Recommendation
The CHMP issued a positive opinion to extend Dupixent (dupilumab) approval for children aged two to 11 with chronic spontaneous urticaria unresponsive to antihistamines and naive to anti-IgE therapy, based on two Phase III trials in six to 11-year-olds and a single-arm study in younger children.
2. US FDA Timeline
Sanofi and Regeneron submitted a supplemental biologics licence application for paediatric CSU, with the FDA decision expected by April 2026, potentially opening the US market to Dupixent’s use in children aged two to 11.
3. Japanese Orphan Drug Designation
The Japanese Ministry of Health granted rilzabrutinib orphan status for IgG4-related disease following positive Phase II results, marking the third global orphan designation for this BTK inhibitor and reinforcing Sanofi’s rare disease strategy.