The biologic is approved based on Phase III study data in generalised myasthenia gravis (gMG), which demonstrated that rozanolixizumab facilitated statistically significant improvements in gMG-specific outcomes compared to placebo.
RYSTIGGO® (rozanolixizumab) is the first therapy approved in Europe for adults with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive generalised myasthenia gravis (gMG). The European Commission (EC) has now granted a marketing authorisation for biopharma company UCB’s treatment, as an add-on to standard therapy in patients who have this rare autoimmune condition.
New European approval for generalised myasthenia gravis treatment
EC approval of rozanolixizumab is supported by data from the Phase III MycarinG study, published in The Lancet Neurology in May 2023, according to UCB. Humanised IgG4 monoclonal antibody rozanolixizumab 140 mg/ml solution that once injected, binds to the neonatal Fc receptor (FcRn) resulting in the reduction of circulating IgG, according to the 2023 paper.
In the study, the primary efficacy endpoint was the comparison of the change from baseline between treatment groups (approximately rozanolixizumab 7mg/kg and rozanolixizumab 10mg/kg) compared to placebo in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at Day 43.
“With the European Commission approval of rozanolixizumab, alongside their recent approval of zilucoplan, I am very excited that our gMG portfolio is now approved for use by healthcare professionals across Europe,” commented CEO of UCB, Jean-Christophe Tellier.
Rozanolixizumab is currently under review by regulatory authorities including the UK Medicines and Healthcare products Regulatory Agency (MHRA) and Switzerland (Swissmedic) to treat adults with generalised myasthenia gravis.
In December 2023, the EC authorised ZILBRYSQ®▼ (zilucoplan) as the only complement component 5 (C5) inhibitor for self-administration in adults with generalised myasthenia gravis who are anti-AChR antibody-positive. It is indicated as a subcutaneous, add-on to standard therapy in these patients. The EC’s decision was based on data from a Phase III study that demonstrated zilucoplan’s ability to provide consistent, fast and statistically significant improvements in outcomes in the final week of the study.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
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