Clinical investigation of medicinal products in the treatment of Myasthenia Gravis

There is currently no guidance on clinical investigation of medicinal products in the treatment of Myasthenia Gravis (MG). Although a few medicinal products have been authorised for the treatment of MG, drug development in this area continues actively and represents a rapidly evolving field. This dynamic landscape justifies the need for an up-to-date and comprehensive regulatory guidance. 

Keyword: Myasthenia Gravis, acetylcholine receptor (AChR), muscle-specific tyrosine kinase (MuSK), low-density lipoprotein receptor-related protein 4 (LRP4), guideline, confirmatory trials

Current version

Concept paper on the need of a guideline on clinical investigation of medicinal products in the treatment of Myasthenia Gravis

Draft: consultation open Consultation dates: 13/02/2026 to 30/08/2026 Reference Number: EMA/9533/2026 Summary:

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