UCB Receive the US FDA’s Approval of Zilbrysq (zilucoplan) for the Treatment of Adults with Generalized Myasthenia Gravis
- The US FDA has approved Zilbrysq for gMG in adult patients who are AChR Ab+. The approval was based on the P-III study (RAISE) results of Zilbrysq (SC, 0.3mg/kg) vs PBO, published in The Lancet Neurology
- The study demonstrated that Zilbrysq provides rapid, consistent & significant benefits in different patient & clinician-reported outcomes at 12wk., improvements in MG-specific efficacy outcomes & significant improvement from baseline for MG-ADL & QMG total score while other 2EPs incl. the proportion of patients with improvements of 3 & 5 points in the MG-ADL & QMG total score at 12wk. without rescue therapy
- Zilucoplan was approved in Japan for gMG in adult patients who inadequately respond to steroids or other immunosuppressants & is under review by TGA & Health Canada
Ref: PR Newswire | Image: UCB
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