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UCB Receives MHLW Approval of Rystiggo (rozanolixizumab) and Zilbrysq (zilucoplan) for Adult Patients with Generalized Myasthenia Gravis in Japan

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UCB Receives MHLW Approval of Rystiggo (rozanolixizumab) and Zilbrysq (zilucoplan) for Adult Patients with Generalized Myasthenia Gravis in Japan

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  • The approval of rozanolixizumab was based on the P-III study (MycarinG) in 200 adult patients with gMG, which showed a reduction in MG-ADL score from baseline to Day 43 was greater in rozanolixizumab (7mg/kg) group and (10mg/kg group) vs PBO while secondary efficacy EPs incl. change from baseline to Day 43 in the QMG
  • The approval of zilucoplan was based on the P-III study (RAISE) in 174 adult patients with anti-AChR Ab+ gMG, which showed a significant & clinical difference favoring zilucoplan over PBO in the MG-ADL & QMG total score change from baseline while 2EPs incl. change from baseline to 12wk. in QMG, MGC & MG-QoL15r
  • Improvements in fatigue were reported as an exploratory EP. Both studies' results were published in The Lancet Neurology

 

Ref: Pharmiweb | Image: UCB

Related News:- UCB Reports the Commercial Availability of Rystiggo (rozanolixizumab-noli) for Adult Patients with Generalized Myasthenia Gravis in the US

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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 connect@pharmashots.com.

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