Janssen-Cilag International NV, a Johnson & Johnson company, announced the submission of the Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, seeking first approval of nipocalimab for the treatment of people living with generalized myasthenia gravis, or gMG. “We are encouraged by the potential of nipocalimab to provide sustained disease control for people living with generalised myasthenia gravis, a chronic, life-long disease,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine. “The filing for approval of nipocalimab represents an important step forward as Johnson & Johnson continues to push the boundaries of research to develop innovative solutions to treat autoantibody-driven diseases, building on decades of expertise in neuroscience and immunology. We look forward to working with the EMA in their review of the data supporting the submission.”
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