Special Episode: FDA Approves Zilucoplan for Myasthenia Gravis
Oct 23, 2023, 08:00 PM
Welcome to this special episode of the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. For major FDA decisions in the field of neurology, we release short special episodes to offer a snapshot of the news, including the main takeaways for the clinical community, as well as highlights of the efficacy and safety profile of the agent in question.
In this episode, we're covering the recent approval of zilucoplan (Zilbrysq; UCB Pharma) for the treatment of patients with acetylcholine receptor antibody–positive generalized myasthenia gravis. We spoke with James F. “Chip” Howard, MD, Distinguished Professor of Neuromuscular Disease and professor of neurology and medicine at The University of North Carolina at Chapel Hill School of Medicine, and the lead global investigator of the phase 3 RAISE study (NCT04115293), who discussed the downstream effects of this approval for myasthenia gravis, the available data from clinical studies, and the advantages for patients and physicians.
In this episode, we're covering the recent approval of zilucoplan (Zilbrysq; UCB Pharma) for the treatment of patients with acetylcholine receptor antibody–positive generalized myasthenia gravis. We spoke with James F. “Chip” Howard, MD, Distinguished Professor of Neuromuscular Disease and professor of neurology and medicine at The University of North Carolina at Chapel Hill School of Medicine, and the lead global investigator of the phase 3 RAISE study (NCT04115293), who discussed the downstream effects of this approval for myasthenia gravis, the available data from clinical studies, and the advantages for patients and physicians.
For more of NeurologyLive®'s coverage of zilucoplan's approval, head here: FDA Approves Complement C5 Inhibitor Zilucoplan as Treatment for Myasthenia Gravis
Episode Breakdown:
- 0:30 – Zilucoplan approved for AChR+ myasthenia gravis
- 1:40 – James F. Howard, MD, on his immediate reaction
- 3:30 – Safety data from the RAISE trial
- 4:25 – Howard on the potential advantages of zilucoplan
- 6:50 – Phase 3 efficacy data for zilucoplan
- 7:55 – Howard with context on the efficacy and the challenges with therapeutic availability in myasthenia gravis
- 12:10 – Howard, on the future of therapeutic development
Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.
REFERENCES
1. UCB announces US FDA approval of Zilbrysq (zilucoplan) for the treatment of adults with generalized myasthenia gravis. News release. October 17, 2023. Accessed October 17, 2023. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-US-FDA-approval-of-ZILBRYSQR-zilucoplan-for-the-treatment-of-adults-with-generalized-myasthenia-gravis
2. Howard JF, Bresch S, Genge A, et al. Safety and efficacy of zilucoplan in patients with generalized myasthia gravis (RAISE): a randomized, double-blind, placebo-controlled, phase 3 study. 2023;22(5):395-406. doi:10.1016/S1474-4422(23)00080-7
3. Genge A, Hussain Y, Kaminski HJ, et al. Safety and tolerability of zilucoplan in RAISE-XT: a multicenter, open-label extension study in patients with myasthenia gravis. Presented at: MDA 2023; February 19-22; Dallas, TX. Abstract 145.