JNJ releases positive data on nipocalimab for myasthenia gravis in adolescents
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- Johnson & Johnson (NYSE:JNJ) said that a phase 2/3 trial of nipocalimab for myasthenia gravis met its primary endpoint in adolescents between 12 and 17 years old.
- Patients treated with nipocalimab plus standard of care saw a reduction in total serum IgG of -69%. Two secondary endpoints, MG-ADL and QMG, which are measures of disease activity, were also met. Also, four out of five patients achieved minimum symptom expression by the end of treatment.
- Results from the Vibrance-MG trial mirrored those seen in a pivotal trial in adults.
- J&J has already submitted applications for nipocalimab in myasthenia gravis to the U.S. FDA and the European Medicines Agency.