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The Expert Committee, after evaluation, declines to list the medicine proposed in the application.
The Model List of Essential Medicines reports reasons that Committee Members have identified for denying listing.
Rejected
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Rejected
ATC codes: L04AC03
EMLc
Indication
Juvenile systemic arthritis ICD11 code: FA24.4
INN
Anakinra
Medicine type
Biological agent
List type
Complementary
Formulations
Parenteral > General injections > SC: 100 mg per 0.67 mL in pre-filled syringe
EML status history
Application rejected in 2021 (TRS 1035)
Application rejected in 2023 (TRS 1049)
Sex
All
Age
Also recommended for children
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Main patents have expired but secondary patents might remain active in some jurisdictions. For more information on specific patents and license status for developing countries visit www.MedsPal.org
Wikipedia
DrugBank
Summary of evidence and Expert Committee recommendations
The Expert Committee did not recommend the inclusion of anakinra for treatment of systemic onset juvenile idiopathic arthritis (SOJIA) with macrophage activation syndrome (MAS), nor of tocilizumab for treatment of SOJIA on the EML and EMLc. As was the case when these medicines were considered in 2021, the Expert Committee considered that the clinical benefits and safety of these medicines (including risk of infection) remain uncertain based on the limited available evidence. The Committee also considered that the feasibility of use of these medicines, particularly in low-resource settings was unlikely given their current high prices, and requirements for specialized care and monitoring and management of adverse events.