JnJ seeks USFDA nod of Stelara for pediatric Crohn's disease
Horsham: Johnson & Johnson is seeking the U.S. Food and Drug Administration (FDA) approval for the expansion of STELARA (ustekinumab) for the treatment of children two years and older with moderately to severely active Crohn’s disease (CD). The company has submitted supplemental Biologics License Application (sBLA) to the USFDA in this connection.
STELARA is currently approved for the treatment of adults living with moderately to severely active CD and ulcerative colitis, in addition to the treatment of adults and children six years and older with active psoriatic arthritis and moderate to severe plaque psoriasis.
The sBLA is supported by data from the Phase 3 UNITI-Jr clinical study, a multicenter, open-label study to evaluate the efficacy, safety, and pharmacokinetics of STELARA for the treatment of pediatric CD through 52 weeks.
“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,” said Chris Gasink, M.D., Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. “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.”
Of the nearly one million people in the U.S. living with CD, approximately up to 25 percent are children and the rate of CD in this younger population continues to rise. Crohn’s disease can be more severe for the pediatric population compared to adults, further highlighting the need for additional treatment options.
Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors. Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn’s disease. Nearly one million people in the U.S. are living with CD, approximately up to 25 percent of those individuals are pediatric.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA.
