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FDA ApprovalMarch 27, 20261
FDA Approves Inebilizumab for Myasthenia Gravis Treatment
The anti-CD19 monoclonal antibody inebilizumab received FDA approval for the treatment of generalized acetylcholine receptor or MuSK-positive myasthenia gravis.
Dijital beyin - farmakolojik calisma
New Biologic Agent for MG
Inebilizumab is an anti-CD19 monoclonal antibody that depletes autoantibody-producing B-cells, representing an expanding group of immunotherapies for myasthenia gravis.
Phase 3 Clinical Trial
In a randomized trial of 238 AChR-positive or MuSK-positive MG patients, inebilizumab showed greater improvement in functional symptoms versus placebo at 26 weeks, leading to FDA approval.
Source: UpToDate - Whats New in Neurology