MFDS Approves Treatment for Myasthenia Gravis
Approval of Imported Rare Drug Vibgatju
Expanding Treatment Options for Myasthenia Gravis Patients
The Ministry of Food and Drug Safety announced on the 20th that it has approved the rare drug 'Vibgatju (efgatigimod alpha)' used to treat adult patients with generalized myasthenia gravis who are positive for anti-acetylcholine receptor antibodies.
Vibgatju works by blocking the binding of autoantibody IgG to the neonatal Fc receptor (FcRn), promoting the degradation of autoantibodies, thereby showing therapeutic effects in patients with myasthenia gravis mediated by autoantibodies.
This drug is the first in Korea to be approved as a therapeutic agent with a new mechanism of action that binds to FcRn. Through this approval, it is expected that the range of treatment options for adult patients with generalized myasthenia gravis will expand.
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Meanwhile, the Ministry of Food and Drug Safety designated this drug as the 22nd product under the 'Global Innovative Product Fast-Track Review System' and expedited its review to ensure rapid introduction into the treatment field for patients with myasthenia gravis in Korea.
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