CHMP positive for Rystiggo (rozanolixizumab) to treat generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. - UCB
UCB has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorization for rozanolixizumab as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive
Rozanolixizumab 140 mg/ml solution for injection is a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG. If approved by the European Commission, rozanolixizumab will be the first emerging therapy approved in Europe for adults with both anti-AChR and anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.
In September 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also issued a positive opinion recommending granting marketing authorization for UCB’s zilucoplan in the European Union (EU) as an add-on to standard therapy for the treatment of gMG in adult patients who are anti-AChR antibody-positive4. Zilucoplan is a once-daily subcutaneously (SC)-injected, self-administered peptide inhibitor of complement component 5 (C5 inhibitor).
In progressing a portfolio of medicines for the treatment of gMG, with the aim of providing HCPs the option of addressing either complement activation or pathogenic antibodies for appropriate patients, UCB hopes to offer a comprehensive portfolio of targeted therapeutics, embodying a commitment to addressing the gMG community’s unmet needs.
“There is a significant need to bring more targeted, well-tolerated, effective treatment options that address the pathophysiology of gMG disease. If approved by the European Commission, UCB will be the first and only company to offer a gMG-focused portfolio with rozanolixizumab and zilucoplan, providing patients and clinicians the option of two targeted therapies. We believe that the inclusion of both anti-muscle-specific tyrosine kinase (MuSK) antibody positive patients and anti-AChR positive patients within the CHMP marketing authorization recommendation for rozanolixizumab could support clinicians to tailor their prescribing decisions to meet individual needs of their patients.’ said Iris Loew-Friedrich, Executive Vice-President and Chief Medical Officer at UCB. ‘This latest European gMG regulatory milestone, alongside approvals for both zilucoplan and rozanolixizumab in the U.S. and Japan in recent months, further reinforces the commitment we have made to the gMG community to help transform their experiences, outcomes and expectations. We are truly proud and excited for the future.”
The CHMP opinion for rozanolixizumab is supported by safety and efficacy data from the pivotal Phase III MycarinG study (NCT03971422), published in The Lancet Neurology in May 2023 (previously cited).
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