European Commission Approves Uplizna for Generalised Myasthenia Gravis

First-in-class B-cell therapy now available as an add-on treatment for adults with gMG, supported by Phase III MINT trial outcomes.

The European Commission has approved Uplizna (inebilizumab) as an add-on therapy for adults with generalised myasthenia gravis (gMG) who are anti-AChR or anti-MuSK antibody positive.

This approval, supported by the Phase III MINT trial, provides a first-in-class B-cell therapy with twice-yearly maintenance dosing and potential to reduce long-term steroid use, broadening treatment options for both AChR+ and MuSK+ patients.

Field	Completed for Uplizna (inebilizumab)
Alert Type	Drug Approval (EC)
Drug Name	Uplizna (inebilizumab)
Indication	Add-on treatment for adults with generalised myasthenia gravis (gMG) who are anti-AChR or anti-MuSK antibody positive
Therapy Area(s)	Neurology / Immunology
Geography	EU (European Commission)
What Changed	The European Commission approved Uplizna as an add-on therapy for adults with generalised myasthenia gravis (gMG) who are antibody positive, following positive outcomes from the Phase III Myasthenia Gravis Inebilizumab Trial (MINT).
Clinical Relevance	Uplizna provides a new first-in-class B-cell targeted treatment for gMG, offering twice-yearly maintenance dosing and potential decrease in long-term steroid use, broadening therapeutic options for AChR+ and MuSK+ patients.
Source Link	Global Data
Date	13-Feb-2026
Status	Draft
Notes	Supported by the Phase III MINT trial, which included structured steroid tapering and both AChR+ and MuSK+ cohorts. Previously approved in EU for IgG4-related disease (Nov 2025) and for neuromyelitis optica spectrum disorder (AQP4-IgG+ adults).

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