Wedoany.com Report-Dec.3, Johnson & Johnson's Imaavy (nipocalimab) has received European Commission approval as the first FcRn inhibitor for generalised myasthenia gravis (gMG) in both adults and adolescents aged 12 years and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.

The approval, granted on 2 December 2025, extends treatment access to adolescent patients for the first time in this drug class. Imaavy is administered by intravenous infusion every two weeks, compared with weekly subcutaneous dosing for the two currently authorised adult-only FcRn inhibitors in the EU: Argenx's Vyvgart Hytrulo (efgartigimod alfa) and UCB's Rystiggo (rozanolixizumab).

Clinical evidence supporting the decision came from the Phase 3 Vivacity-MG3 study in adults and the Phase 2/3 Vibrance-MG study in adolescents. Both trials demonstrated that Imaavy, when added to standard background therapy, significantly reduced pathogenic auto-antibody levels and improved disease control.

Generalised myasthenia gravis affects an estimated 56,000 to 123,000 people across Europe. More than 90 percent of antibody-positive patients carry anti-AChR or anti-MuSK antibodies, leading to symptoms including severe muscle weakness and difficulties with speech, swallowing, and breathing.

Prof Francesco Saccà, neurology specialist at University Federico II of Naples, Italy, welcomed the approval: "Even with advances in treatment, people living with generalised myasthenia gravis continue to experience unpredictable symptom fluctuations that can disrupt daily life. With strong data from the Vivacity-MG3 and Vibrance-MG studies, nipocalimab provides an important new option that could help achieve sustained disease control and support greater stability for patients managing this challenging condition."

Imaavy has also secured regulatory clearance for gMG in the United States, Brazil, and Japan. Johnson & Johnson acquired the asset through its 2020 purchase of Momenta Pharmaceuticals for $6.5 billion.

Beyond gMG, nipocalimab is in clinical development for several other auto-antibody-driven conditions, including rheumatoid arthritis, systemic lupus erythematosus, Sjögren's disease, idiopathic inflammatory myopathies, and haemolytic disease of the foetus and newborn.

The approval strengthens treatment options for a broader patient population in Europe and marks a significant expansion of FcRn inhibition therapy into the adolescent age group, offering physicians an additional tool to manage this chronic autoimmune disorder effectively.