Johnson & Johnson submits application for golimumab to treat pediatric ulcerative colitis patients

Johnson & Johnson submits application for golimumab to treat pediatric ulcerative colitis patients | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

With the submission of a supplemental biologics license (sBLA) application for golimumab (Simponi), Johnson & Johnson is seeking expanded approval of the anti-TNF biologic to include pediatric patients aged 2 years and older with moderately to severely active ulcerative colitis (UC).¹

According to a press release from Johnson & Johnson, the sBLA is supported by data from the PURSUIT program, which features multi-center, open-label studies evaluating the efficacy, safety, and pharmacokinetics of subcutaneously-administered golimumab to treat pediatric UC.¹

Currently, the treatment is approved in adults with moderately to severely active UC.¹

"This submission marks an important step in addressing the unique and pressing high unmet needs of children and adolescents living with [UC], a challenging and lifelong inflammatory disease,” Esi Lamousé-Smith, MD, PhD, Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine, stated in a press release.¹

"We are committed to designing clinical programs that prioritize underrepresented populations, including pediatric patients living with immune-mediated diseases, to ensure access to safe and effective treatment options," said Lamousé-Smith. "We look forward to working with the Agency in their review of this [golimumab] pediatric application."¹

A form of inflammatory bowel disease (IBD), UC causes inflammation in the digestive tract, which can result in damage to the colon lining. According to Johnson & Johnson, UC impacts more than 1 million people in the United States, presenting challenges for treatment in the pediatric population.¹

According to the University of California San Francisco (UCSF) clinical trials, the phase 3 PURSUIT 2 study (NCT03596645) is currently in progress and not accepting new patients in the evaluation of efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active UC.²

As of December 4, 2024, approximately 84 individuals aged 2 to 17 years were participating, and according to UCSF, inclusion criteria included²:

• "Must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or azathioprine OR must either have or have had a history of corticosteroid dependency (that is an inability to successfully taper corticosteroids without a return of the symptoms of UC OR required more than 3 courses of corticosteroids in the past year."
• "Moderately to severely active UC (as defined by baseline Mayo score of 6 through 12 [endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist], inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal to (>=2)."
• "If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at Week 0. Participants who receive parenteral nutrition are not permitted to enroll in the trial."
• "No history of latent or active tuberculosis prior to screening."
• "Must be up to date with all immunizations (that is, measles, mumps, rubella, and varicella) in agreement with current local immunization guidelines for immunosuppressed participants before Week 0."

References:

1. Johnson & Johnson submits application seeking U.S. FDA approval of SIMPONI^® (golimumab) for the treatment of pediatric ulcerative colitis. Johnson & Johnson. Press release. December 16, 2024. Accessed December 17, 2024. https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-application-seeking-u-s-fda-approval-of-simponi-golimumab-for-the-treatment-of-pediatric-ulcerative-colitis

2. A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis. University of California San Francisco. Updated December 4, 2024. Accessed December 17m 2024. https://clinicaltrials.ucsf.edu/trial/NCT03596645