UCB’s Rystiggo (rozanolixizumab) Receives the US FDA’s Approval for the Treatment of Adults with Generalized Myasthenia Gravis
- The US FDA has approved Rystiggo for the treatment of adult patients with gMG who are AchR or anti-muscle-specific tyrosine kinase (MuSK) Ab+. The approval was based on the P-III study (MycarinG) evaluating rozanolixizumab in 200 adult patients with gMG with an open-label extension
- The results showed that patients treated with rozanolixizumab resulted in significant improvements in gMG-specific outcomes, incl. everyday activities i.e., breathing, talking, swallowing & being able to rise from a chair, a significant difference was seen in MG-ADL & QMG total score change from baseline
- The product is expected to be commercially available in the US in Q3’23. Rozanolixizumab is currently under EMA & Japan review for the treatment of adults with gMG
Ref: UCB | Image: UCB
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