1. Clinical trials in children and adolescents with systemic lupus erythematosus: methodological aspects, regulatory landscape and future opportunities
2. ClinicalTrials.gov. 2019. Identifier NCT02955615, ILT-101 in Patients with Active Moderate to Severe Systemic Lupus Erythematosus (SLE) (LUPIL-2). National Library of Medicine (US). https://clinicaltrials.gov/ct2/show/NCT02955615 (accessed December 30, 2019)
3. Committee for Medicinal Products for Human Use (CHMP). 2019. Assessment report: Benlysta (Procedure No. EMEA/H/C/002015/II/0062). Amsterdam, The Netherlands: European Medicines Agency. https://www.ema.europa.eu/en/documents/variation-report/benlysta-h-c-2015-ii-0062-epar-assessment-report-variation_en.pdf. (accessed December 30, 2019)
4. Division of Pulmonary Allergy and Rheumatology Products (CDER). 2019. BLA 125370/s-064 and BLA 761043/s-007 Multi-disciplinary Review and Evaluation, Benlysta® (belimumab) for Intravenous Infusion in Children 5–17 Years of Age with SLE. Silver Spring, MD: Food and Drug Administration. https://www.fda.gov/media/127912/download (accessed December 30, 2019)
5. Food and Drug Administration (FDA). 2019. 21 CFR Part 312.42. Clinical holds and request for modification. Revised 1 April 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.42 (accessed December 30, 2019)