Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of STELARA® (ustekinumab) to treat pediatric patients two years and older with moderately to severely active Crohn’s disease. This action could mark the availability of a needed new treatment option for an at-risk patient population.
The filing is supported by encouraging data from the Phase 3 UNITI-Jr clinical trial. The trial, which assessed the safety and efficacy of STELARA® in pediatric patients with Crohn’s disease for 52 weeks, proved that the treatment successfully met its primary endpoint of clinical remission.
Living with a lifelong condition like Crohn’s disease can be incredibly challenging, especially for children and adolescents who may experience more severe symptoms and faster disease progression than adults. With limited approved treatment options to support the specific needs of this patient population, many children with a Crohn’s disease diagnosis continue to struggle,
With the well-established efficacy and safety profile of STELARA in existing indications, this submission aims to better support these patients, their families, and providers with a new treatment option.
Chris Gasink
Crohn’s disease is a type of chronic inflammatory bowel disease (IBD) that significantly affects the quality of life of its sufferers. The disease, when it occurs in children, can be especially difficult and may have an adverse effect on the growth and development of the child. Crohn’s disease is a serious concern within the pediatric population in the United States, which makes availability of safety and efficacy treatment a priority.
STELARA® (ustekinumab) is a human monoclonal antibody that binds to the interleukin (IL)-12 and IL-23 cytokines, which are thought to contribute to the inflammatory process of Crohn’s disease. The medication is currently FDA-approved for the treatment of adult patients with moderately to severely active Crohn’s disease and ulcerative colitis, and for adults and children six years of age and older with psoriatic arthritis and plaque psoriasis.
The possible FDA approval of STELARA® in pediatric Crohn’s disease would present a new treatment choice for children and their families afflicted with this incapacitating illness. Johnson & Johnson’s FDA submission represents an important milestone toward filling the unmet medical needs in children with Crohn’s disease.
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