Rare Daily Staff
The European Commission expanded the approved indications for Swedish Orphan Biovitrum’s Kineret to include the treatment of Still’s disease, a rare systemic multi-organ disorder auto-inflammatory disease.
The approval extends across all 28 European Union member states and includes the use of Kineret for Systemic Juvenile Idiopathic Arthritis and Adult-Onset Still’s Disease. Kineret is already approved in Europe to treat rheumatoid arthritis in combination with methotrexate, as well as a number of other autoimmune conditions.
“Kineret has long been recognized as an effective and safe treatment for rheumatoid arthritis and Cryopyrin-Associated Periodic Syndromes,” said Norbert Oppitz, head of specialty care at Sobi. “With this new indication, patients with Still’s disease will get access to an alternative treatment with an established safety profile.”
The approval is based on data from clinical trials as well as data from scientific literature and meta-analyses of published data. Overall, the evaluation of the medicine is based on more than 400 patients with Still’s disease. It shows the efficacy of Kineret in both pediatric and adult patients with Still’s disease, with the majority of patients achieving remission, as well as an improvement of the signs and symptoms associated with the condition.
Safety data from the clinical trials and published literature in Still’s disease, together with safety data from post-marketing use of Kineret since 2002 in both Still’s disease and other indications, show that the most common adverse events are reactions at the site of injection, headache and increased total blood cholesterol.
April 11, 2018
Photo: Norbert Oppitz, head of specialty care at Sobi