On Tuesday, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s (NYSE:JNJ) Simponi (golimumab) for children with moderately to severely active ulcerative colitis (UC) who weigh at least 15 kg.
The approval is supported by data from the PURSUIT program, which included two multi-center, open-label studies to evaluate the efficacy, safety, and pharmacokinetics of subcutaneously administered Simponi for pediatric ulcerative colitis.
