Swedish Orphan Biovitrum AB (Sobi), an international specialty healthcare company dedicated to rare diseases, together with its Australian partner, A. Menarini Australia Pty Ltd, a member of the Menarini Group, a leading European biopharmaceutical company, received marketing authorisation in Australia for Kineret (anakinra) for the treatment of systemic juvenile idiopathic arthritis (SJIA), which is a rare form of juvenile chronic arthritis.
"We are pleased and encouraged by this approval which was achieved through a fruitful collaboration between physicians, regulators, and our development team including Menarini. We are looking forward to serving a wider group of patients in Australia going forward," says Kristina Timdahl, medical therapeutic area head for the business area Inflammation at Sobi.
Systemic juvenile idiopathic arthritis (SJIA) is a rare form of chronic arthritis in children up to 16 years of age. About 100 of 100,000 children are affected by child arthritis, and of these 10-20 per cent have the sJIA form, today classified as an autoinflammatory disease. The disease does not only cause inflammation of the joints but also fever spikes, rash, anaemia, and enlargement and inflammation of major organs. Despite treatment, many children suffer life-long and serious complications such as osteoporosis and stunted growth.
Kineret is a recombinant protein drug that blocks the biological activity of IL-1a and IL -1b by binding to interleukin-1 type 1 receptor (IL-R 1), expressed in a variety of tissues and organs, and thereby blocking the interleukin-1 (IL-1) signalling. IL-1 is a key mediator of inflammation and a significant contributor to autoinflammatory diseases.