Primary source: Inspections and Compliance
Stelara is now approved for a new indication—treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients aged 2 years and older.
This approval expands the therapeutic options available for pediatric patients suffering from UC, a chronic condition that can lead to significant health complications.
Update labeling to reflect the new indication for Stelara, and ensure compliance with associated regulatory activities including safety monitoring.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Update labeling to reflect the new indication for Stelara, and ensure compliance with associated regulatory activities including safety monitoring.
Stelara (ustekinumab) has received FDA approval for treating pediatric patients aged 2 years and older with moderately to severely active ulcerative colitis (UC). This is the first monoclonal antibody approved for pediatric inflammatory bowel disease that does not target TNFα.
What changed: Stelara is now approved for a new indication—treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients aged 2 years and older.
Why it matters: This approval expands the therapeutic options available for pediatric patients suffering from UC, a chronic condition that can lead to significant health complications.
Practical implication: Update labeling to reflect the new indication for Stelara, and ensure compliance with associated regulatory activities including safety monitoring.
Published from the regulator source ingestion pipeline after PV impact triage.
Labeling and risk management updates are required to reflect the new drug approval, including the incorporation of safety and efficacy data from the VERIFY trial.
Customers are required to quarantine affected kits, complete response forms, and destroy the kits. Notification must also be sent to distributors who should inform their customers of these updated actions.
Health care professionals must complete and return the enclosed Reply Verification Tracking Form (RVTF) indicating the quantities of affected units to return, and monitor patients following the standard of care while discontinuing the use of these catheters.
Regulatory teams must update product labeling to reflect the new indication and assess signal management considerations for capivasertib.
