SOBI has announced that Kineret (anakinra) has been approved by the European Commission (EC) for the treatment of Still’s disease (Systemic Juvenile Idiopathic Arthritis [SJIA] and Adult-Onset Still’s Disease [AOSD]), in all 28 European Union (EU) member states. Still’s disease is a rare systemic multi-organ disorder of auto-inflammatory nature that affects approximately 25,000 children and adults in the EU. In children and may lead to a severe inflammatory arthritis in up to 30% of those affected.
The EU indication reads:
- Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still’s disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still’s Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.
- Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).”
Anakinra is a recombinant interleukin-1 receptor antagonist, first approved for use in the USA in 2001, for the treatment of rheumatoid arthritis. includes an option for first line treatment as an alternative to steroid treatment.”
Anakinra is also approved for the treatment of the Cryopyrin-Associated Periodic Syndromes (CAPS).
The approval is based on data from clinical trials as well as data from scientific literature and meta-analyses of published data.