The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Sobi’s Kineret (anakinra) as a new treatment for systemic juvenile idiopathic arthritis, a condition also known as Still’s disease.
Still’s disease refers to both systemic juvenile idiopathic arthritis (SJIA) and adult-onset Still’s disease (AOSD). The auto-inflammatory rare disorder can affect several organs and is often associated with fever, rash, and joint inflammation.
Kineret is approved in Europe and the U.S. to reduce the signs and symptoms of rheumatoid arthritis in combination with methotrexate in patients who had an inadequate response to methotrexate alone.
The drug blocks the attachment of a protein called interleukin-1 (IL-1) to its receptors. IL-1 plays an important role in the immune system, and can cause uncontrollable inflammation if produced in excess. Kineret blocks the activity of IL-1, helping to reduce inflammation and relieve the symptoms of arthritis.
The treatment is also indicated for other conditions, namely cryopyrin-associated periodic syndromes (CAPS), including neonatal-onset multisystem inflammatory disease (NOMID)/chronic infantile neurological, cutaneous, articular syndrome (CINCA); Muckle-Wells syndrome (MWS); and familial cold auto-inflammatory syndrome (FCAS).
Sobi hopes to add SJIA and AOSD to the list of medical conditions for which Kineret treatment is indicated.
Kineret can be administered as a monotherapy or in combination with other disease modifying anti-rheumatic drugs (DMARDS) and anti-inflammatory drugs. The treatment is indicated for patients older than 8 months who have a body weight of at least 22 pounds.
Similarly, the new proposed indication for Still’s disease includes adults, adolescents, children and infants older than 8 months with a body weight of at least 22 pounds, and adds patients with discontinued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDS) or glucocorticoids.
“We are very pleased with the CHMP positive opinion which recommends including this indication for Kineret in the EU,” Milan Zdravkovic, Sobi’s chief medical officer and head of research and development, said in a press release.
“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,” he added.
When a pharmaceutical company applies for marketing authorization for a new product in Europe, the CHMP gives either a positive or negative recommendation. The EMA then makes a final decision taking into account the scientific opinion of the CHMP.