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EMA Drug Approvals | Europe drug approvals | 2024 | iPharmaCenter

Updated: Jan 14


Sl No

Brand

Manufacturer

Indication

1

Rystiggo

UCB

Myasthenia gravis


January 08, 2024

EC approved Rystiggo for gMG

UCB has received approval from the European Commission (EC) for Rystiggo (rozanolixizumab) as a supplementary element to conventional therapy for the management of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.


Rozanolixizumab, a humanized IgG4 monoclonal antibody with a 140 mg/ml solution for injection, attaches to the neonatal Fc receptor (FcRn), leading to decreased circulating IgG. This signifies validation as the primary therapy in Europe for adults with anti-AChR or anti-MuSK antibody-positive gMG, covering the two most common gMG subtypes.


The EC's choice ensues their earlier endorsement of UCB's Zilbrysq (zilucoplan) in December 2023 for managing adult patients with gMG who are anti-AChR antibody-positive. Zilucoplan, delivered once daily through subcutaneous injection, functions as a self-administered peptide inhibitor of complement component 5 (C5 inhibitor).


The EC validation for rozanolixizumab is validated by safety and effectiveness information from the pivotal Phase 3 MycarinG study (NCT03971422), disclosed in The Lancet Neurology in May 2023. The study exhibited statistically significant and clinically meaningful enhancements in gMG-specific outcomes compared to a placebo. Rozanolixizumab manifested effectiveness in the primary endpoint of the MG-ADL score at Day 43, indicating advancements in activities like breathing, talking, swallowing, and rising from a chair. Secondary effectiveness endpoints, comprising the Myasthenia Gravis Composite (MG-C) and the Quantitative Myasthenia Gravis (QMC) scores, further validated rozanolixizumab's efficiency. The MG-C score alteration from baseline to Day 43 unveiled a statistically significant contrast favoring rozanolixizumab over the placebo. Moreover, the QMG total score alteration from baseline to Day 43 displayed noteworthy enhancements with rozanolixizumab compared to the placebo.


Adverse reactions documented in the rozanolixizumab EU Summary of Product Characteristics involve headache (48.4%), diarrhea (25.0%), and fever (12.5%).


Generalized myasthenia gravis (gMG) is an uncommon, persistent autoimmune ailment influencing the neuromuscular junction, with a worldwide prevalence of 100–350 cases per every 1 million individuals.


This EC validation aligns with prior validations by the Japanese Ministry of Health, Labour and Welfare (MHLW) and the U.S. Food and Drug Administration (FDA) for rozanolixizumab and zilucoplan, correspondingly, in the treatment of gMG in grown-up patients.

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