golimumab – BiotechReality – Information Intelligence System for Biopharma

The U.S. Food and Drug Administration (FDA) has approved SIMPONI® (golimumab), Johnson & Johnson said, for the management of children weighing at least 15 kg who have moderately to severely active ulcerative colitis (UC). This approval extends SIMPONI® (golimumab)'s current approval for adults with moderately to highly active UC, a chronic inflammatory bowel disease that affects over a million Americans, and represents the drug's first pediatric indication. Read More: FDA Delays Approval of Johnson & Johnson’s Four-Drug Myeloma Therapy Data from the PURSUIT program, including two multi-center, open-label studies assessing the pharmacokinetics, safety, and effectiveness of subcutaneously administered SIMPONI® (golimumab) in pediatric UC, support the FDA's decision. 32% of patients reached the primary objective of clinical remission at Week 6. In Week 6, 58% of patients had a clinical response. At Week 6, 40% of patients had endoscopic improvement. 57% of patients who were in clinical remission at Week 6 continued to have clinical remission at Week 54. The safety findings in this child population were in line with those found in SIMPONI® (golimumab) clinical trials in UC patients. Read More: Johnson & Johnson’s Bleximenib Combination Therapy Shows High Response Rates in Tough-to-Treat Acute Myeloid Leukemia A pre-filled syringe is used to give SIMPONI® (golimumab). After receiving the necessary instruction from a medical professional, patients 12 years of age and older may administer the injection themselves. The dosage is determined by weight: 200 mg at Week 0 and 100 mg at Weeks 2, 6, and every 4 weeks after that for patients weighing more than 40 kg. 100 mg at Week 0 and 50 mg at Weeks 2, 6, and every 4 weeks after that for patients weighing between 15 kg and less than 40 kg. Johnson & Johnson's dedication to meeting the unmet needs of individuals with chronic immune-mediated disorders is demonstrated by this new indication. Active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), moderately to severely active UC in adults and now pediatric patients, and moderate to severe rheumatoid arthritis (RA) are the five indications for which SIMPONI® (golimumab) is currently licensed. Information: Johnson&Johnson Last Modified:

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U.S. FDA Approves Johnson & Johnson’s SIMPONI® (golimumab) for Pediatric Ulcerative Colitis

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