Efgartigimod: First Approval

Article Clinical Neurology

Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT) : a multicentre, randomised, placebo-controlled, phase 3 trial

James F. Jr Jr Howard et al.

Summary: The study evaluated the safety and efficacy of efgartigimod in patients with generalised myasthenia gravis, showing that it was well tolerated and efficacious. The unique feature of individualized dosing based on clinical response in the study will provide further insights into clinical practice with longer term data from the ongoing open-label extension.

LANCET NEUROLOGY (2021)

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Editorial Material Clinical Neurology

NEUROMUSCULAR DISEASE Getting specific: targeting Fc receptors in myasthenia gravis

Jan D. Lunemann

Summary: A randomized, placebo-controlled trial found efgartigimod to be an effective therapy for generalized myasthenia gravis. If the pending FDA application is approved, it will be the first recombinant antibody-based therapy for selective IgG depletion, expanding the treatment options for myasthenia gravis.

NATURE REVIEWS NEUROLOGY (2021)

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Review Clinical Neurology

The importance of FcRn in neuro-immunotherapies: From IgG catabolism, FCGRT gene polymorphisms, IVIg dosing and efficiency to specific FcRn inhibitors

Marinos C. Dalakas et al.

Summary: The genetics of FCGRT may affect the clearance and duration of infused IgG, impacting the effectiveness of IVIg in autoimmune neurological diseases. Monoclonal antibodies targeting FcRn show promise in treating antibody-mediated neurological diseases, particularly in cases where high IVIg doses are needed for efficacy.

THERAPEUTIC ADVANCES IN NEUROLOGICAL DISORDERS (2021)

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Article Hematology