Johnson & Johnson (J&J) declared that it has applied to the FDA in the United States to broaden the use of its biologic therapy, STELARA® (ustekinumab), for treating children with moderately to highly active ulcerative colitis (UC).
A supplemental biologics licence application (sBLA) was submitted by the company’s Innovative Medicine division in search of a new indication for STELARA® in children aged two and up. The purpose of this contribution is to present a novel treatment option for a younger patient population that frequently faces major obstacles in the management of chronic inflammatory bowel disease.
Submission Supported by Phase 3 Trial Data
Comprehensive findings from the Phase 3 UNIFI Jr clinical trial support the sBLA. Through Week 52, the pharmacokinetics, safety, and effectiveness of STELARA® in paediatric subjects were assessed in this multicenter interventional research. The trial’s successful conclusion offers the proof required to back up the medication’s promise as a treatment for this marginalised population.
Chronic colon inflammation is a hallmark of ulcerative colitis, a kind of inflammatory bowel disease (IBD). About 20% of diagnoses are in children, and the disease is thought to impact one million people in the United States. Compared to adults, children with UC often have more severe symptoms and fewer recognised treatment options.
STELARA’s Existing Approvals
A human interleukin (IL)-12 and IL-23 antagonist, STELARA® (ustekinumab) is already a recognised treatment for a number of immune-mediated diseases. In the US, it is currently authorised for:
- Adults with ulcerative colitis and Crohn’s disease who are moderately to severely active.
- Individuals with active psoriatic arthritis who are adults or youngsters aged six and up.
- Adults with moderate-to-severe plaque psoriasis and kids aged six and up.
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
