European Authorities Clear Novel Autoimmune Therapy for Myasthenia Gravis
Johnson & Johnson's Nipocalimab Receives Regulatory Nod, Offering Treatment for Both Adult and Adolescent Patients, Posing Competition for Established FcRn Inhibitors
The European Commission has granted authorization for nipocalimab, an immunoglobulin G (IgG) receptor antagonist developed by Johnson & Johnson, for the management of generalized myasthenia gravis (gMG). This landmark decision permits the use of the medicine in patients who are 12 years of age and older and whose condition is characterized by the presence of anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibodies.
The clearance establishes the drug as the initial therapy in the class of Fc receptor blockers available to both adults and younger individuals across the European Union. Previously approved treatments in this category, namely products from Argenx and UCB, are only authorized for the adult population within the EU market. The new treatment is administered through an infusion into a vein bi-weekly. In contrast, existing market options are typically delivered as a weekly injection beneath the skin.
This regulatory milestone was supported by efficacy data gathered from two clinical programs: the Phase 3 Vivacity-MG3 study involving adult participants and the Phase 2/3 Vibrance-MG study for adolescents. The trials showed that adding the drug to existing therapeutic regimens successfully decreased the concentration of pathological auto-antibodies in patients.
Generalized myasthenia gravis is a progressive autoimmune illness that manifests as profound muscle weakness, potentially impairing vital functions such as breathing, articulation, and deglutition (swallowing). It is estimated that this condition affects between 56,000 and 123,000 individuals across the European continent. The majority of antibody-positive gMG cases, over 90%, involve either anti-AChR or anti-MuSK positivity.
Johnson & Johnson secured the rights to nipocalimab through its acquisition of Momenta Pharmaceuticals in 2020, a transaction valued at $6.5 billion. Beyond gMG, the compound is currently undergoing clinical assessment for several other immune-mediated disorders, including but not limited to systemic lupus erythematosus (SLE) and rheumatoid arthritis. The pharmaceutical firm projects that the product has the potential to generate annual sales exceeding $5 billion, a figure that would help mitigate the impending revenue decline resulting from the loss of patent protection for key revenue drivers like the immunology drug ustekinumab.
Source:Â https://pharmaphorum.com/news/jj-gets-eu-approval-imaavy-gmg
