Sobi has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for anakinra for the treatment of Still’s disease.
The opinion is now referred to the European Commission for a decision.
Still’s disease is a rare systemic multi-organ disorder of auto-inflammatory nature that affects both children and adults. It is often associated with fever, rash and joint inflammation. Still’s disease is also referred to as systemic juvenile idiopathic arthritis or adult-onset Still’s disease.
“We are very pleased with the CHMP positive opinion which recommends including this indication for Kineret in the EU. Sobi is committed to improving the lives of people affected by rare diseases, and this recommendation, if approved by the European Commission, would help address an unmet medical need for people with Still’s disease,” says Milan Zdravkovic, Chief Medical Officer and Head of Research and Development at Sobi.
In addition to current indications, the proposed new 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).”