Rare Disease Drug "Rystiggo Injection" for Myasthenia Gravis Approved by Ministry of Food and Drug Safety

The Ministry of Food and Drug Safety announced on April 24 that it has approved the rare disease drug "Rystiggo Injection" (ingredient: rozanolixizumab) for the treatment of generalized myasthenia gravis, a rare disease.

Generalized myasthenia gravis is an autoimmune disease characterized by decreased neuromuscular signal transmission and generalized muscle weakness, caused by autoantibody IgG (immunoglobulin G) targeting components of the neuromuscular junction.

Rystiggo Injection treats patients with generalized myasthenia gravis by inhibiting the binding of IgG to the neonatal Fc receptor (FcRn), which is involved in antibody recycling, thereby reducing the concentration of pathogenic IgG autoantibodies.

FcRn is specific to the homeostasis of antibody IgG in the body and prevents IgG from being degraded by lysosomes.

The Ministry of Food and Drug Safety expressed its expectation that this approval will expand the range of treatment options for adult patients with generalized myasthenia gravis.

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