UCB Receives the EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Zilucoplan for Adults with Generalized Myasthenia Gravis
- The opinion was based on the P-III study (RAISE) evaluating zilucoplan (0.3mg/kg, SC) vs PBO in a ratio (1:1) in adult patients with AChR Ab+ gMG which showed improvements in gMG-specific efficacy outcomes, significant and clinical difference favoring zilucoplan was observed in the MG-ADL total score change from baseline
- The 2EPs incl. a change from baseline to 12wk. in QMG, MGC, and MG-QoL15r., significant & clinical difference was seen in QMG total score change from baseline to 12wk. The results were published in the Lancet Neurology journal
- Zilucoplan is currently under review by PMDA, US FDA, TGA & Health Canada for gMG. Responses from the PMDA & US FDA are expected at the end of Q4 2023; from TGA & Health Canada are expected by H1’24
Ref: UCB | Image: UCB
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at firstname.lastname@example.org
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at email@example.com.