The European Commission has approved Amgen’s UPLIZNA® (inebilizumab) as an add-on treatment for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. This approval offers a new targeted treatment option with twice-yearly maintenance dosing, bringing a first-in-class approach for durable disease control. The decision is supported by data from the MINT study, which showed significant improvement in gMG symptoms and the potential to reduce long-term steroid use.
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EUROPEAN COMMISSION APPROVES AMGEN'S UPLIZNA® FOR GENERALIZED MYASTHENIA GRAVIS
The European Commission has approved Amgen’s UPLIZNA® (inebilizumab) as an add-on treatment for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. This approval offers a new targeted treatment option with twice-yearly maintenance dosing, bringing a first-in-class approach for durable disease control. The decision is supported by data from the MINT study, which showed significant improvement in gMG symptoms and the potential to reduce long-term steroid use.