17 October 2023 - US FDA approval of zilucoplan is built on the pivotal Phase 3 RAISE study in generalised myasthenia gravis, which demonstrated that treatment with zilucoplan resulted in statistically significant improvements in MG specific efficacy outcomes compared to placebo.
UCB today announced that Zilbrysq (zilucoplan) has been approved by the US FDA for the treatment of generalised myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.