Early Consideration from our agency: "Points to Consider in the Development of Drugs for Pediatric Inflammatory Bowel Disease"

Our agency conducts various initiatives to support clinical trial consultations and reviews that appropriately respond to innovation, including the publication of Early Considerations. Early Consideration refers to perspectives presented at a point in time as reference information to promote the practical application of innovation and the development of innovative pharmaceuticals, even at a stage where scientific knowledge and information may not be sufficiently accumulated.
Recently, drugs for IBD have been actively developed. Particularly for moderate to severe IBD, various drugs with different mechanisms of action have been approved every year. However, for the most approved drugs for IBD, the populations in the clinical studies that served as the basis for approval were 18 years or older, and the dosage, administration, efficacy, and safety in pediatric populations remain unknown. Therefore, their package inserts call attention in the section "PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS" that no clinical study in pediatrics has been conducted. Consequently, it is generally understood that treatment options for pediatric IBD patients are not as numerous as those for adult IBD patients.
In 2025, our agency issued an Early Consideration to outline the basic approach to developing drugs for pediatric IBD and to promote such development. We would like to introduce its overview and hope for the advancement of drug development for pediatric IBD through collaboration between academia and pharmaceutical companies.