Posted by Michael Wonder on 15 Sep 2023
UCB receives CHMP positive opinion of zilucoplan for the treatment of adults with generalized myasthenia gravis in Europe
15 September 2023 - The CHMP positive opinion is based on the pivotal Phase 3 RAISE study in generalised myasthenia gravis in adult patients which demonstrated that treatment with zilucoplan resulted in statistically significant and clinically meaningful improvements in gMG-specific efficacy outcomes.
UCB today announced that the CHMP of the EMA has issued a positive opinion recommending granting marketing authorisation for zilucoplan in the European Union as an add-on to standard therapy for the treatment of generalised myasthenia gravis in adult patients who are anti acetylcholine receptor antibody positive.
