Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE)

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• Nipocalimab earning its fifth FDA Fast Track designation, now in systemic lupus erythematosus, reflects the importance of accelerating the delivery of an immunoselective therapy that could fill an unmet need in this serious condition

  80% confidence

• Through close collaboration with the FDA, we seek to advance the development of nipocalimab as a potential new treatment option for the SLE patient community

  80% confidence

• Systemic lupus erythematosus is a serious, complex disease that affects many aspects of a patient's life, and treatment options remain limited

  80% confidence

• Progress like this brings renewed hope for more targeted therapies and meaningful outcomes for people living with this devastating disease

  80% confidence

• Nipocalimab is the only FcRn blocker to demonstrate reduction in SLE disease activity, as shown in the JASMINE study

  80% confidence