Commentary|Podcasts|October 23, 2023
Special Episode: FDA Approves Zilucoplan for Myasthenia Gravis
Author(s)Matt Hoffman
Mind Moments®, a podcast from NeurologyLive®, brings you an exclusive interview with James F. Howard, MD. [LISTEN TIME: 16 minutes]
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A special episode of the NeurologyLive® Mind Moments ® podcast is now live! Scroll down to listen or click here to subscribe on your favorite streaming service.
The Mind Moments® podcast features exclusive interviews with leaders in the field discussing the latest research and disease management strategies across the breadth of neurology, including epilepsy, multiple sclerosis (MS), Parkinson disease, dementia, sleep disorders, and more.
This episode, "FDA Approves Zilucoplan for Myasthenia Gravis," features an exclusive interview 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). He discussed the downstream effects of this approval for myasthenia gravis, the available data from clinical studies, and the advantages for patients and physicians.1-3
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
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.
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