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Johnson & Johnson announces positive CHMP opinion of nipocalimab

Johnson & Johnson announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of nipocalimab, a fully human FcRn-blocking monoclonal antibody, as an add-on to standard therapy for the treatment of generalized myasthenia gravis. “The recommendation is for nipocalimab in a broad population of people living with gMG including adults and adolescent patients 12 years of age and older who are anti-acetylcholine receptor or anti-muscle-specific kinase antibody positive,” the company said in a statement.

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