Policy & Regulation
UCB presents zilucoplan and rozanolixizumab efficacy and safety results in generalised myasthenia gravis
11 May 2022 -

UCB, a global biopharmaceutical company, announced on Tuesday results from two Phase 3 studies evaluating its investigational treatments, zilucoplan, a self-administered, subcutaneous (SC) peptide inhibitor of complement component 5 (C5 inhibitor) and rozanolixizumab, an SC-infused monoclonal antibody targeting the neonatal Fc receptor (FcRn) in adults with generalised myasthenia gravis (gMG).

These results will be presented as posters at the 14th Myasthenia Gravis Foundation of America (MGFA) International Conference on Myasthenia and Related Disorders, taking place from 10-12 May 12022.

The company said that data from the Phase 3 RAISE trial (NCT04115293) (poster 26) demonstrated treatment with zilucoplan (0.3mg/kg daily) resulted in clinically meaningful and statistically significant improvements in key gMG-specific outcomes compared with placebo in patients with acetylcholine receptor autoantibody positive (AChR+) gMG.

The study met its primary endpoint with zilucoplan showing a placebo-corrected mean improvement of 2.12 points in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at week 12 (p



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