European regulators have expanded the scope of Sobi’s Kineret to include the treatment of Still’s disease, a rare, systemic, multi-organ, auto-inflammatory disorder that affects around 25,000 children and adults in the EU.
The new indication allows use of Kineret in adults, adolescents, children and infants aged eight months and older with a body weight of 10kg or above for treatment of the disease, which includes 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 (anakinra) can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).
The approval rides on the back of clinical data and analysis showing the drug’s efficacy in both paediatric and adult patients, with the majority achieving remission as well as an improvement of the signs and symptoms associated with the condition, the firm noted.
On the safety side, the most common adverse events have thus far been injection side reactions, headache and increased total blood cholesterol.
“We are very pleased with the approval of Kineret in Still’s disease in EU. This allows us to address an important unmet medical need in this patient population. It includes an option for first line treatment as an alternative to steroid treatment”, says Milan Zdravkovic, chief medical officer and head of R&D at Sobi.
Kineret is already indicated in Europe for rheumatoid arthritis and for the treatment of cryopyrin-associated periodic syndromes (CAPS).