J&J submits sBLA for pediatric indication for Simponi in ulcerative colitis
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- Johnson & Johnson (NYSE:JNJ) has submitted a supplemental Biologics License Application to the U.S. FDA to add an additional indication for Simponi (golimumab) to include children two years and older with ulcerative colitis.
- The application is backed by data from the PURSUIT program and includes open-label study data on the efficacy, safety, and pharmacokinetics of subcutaneous Simponi for pediatric ulcerative colitis.