Pediatric indication for SOBI’s Kineret from UK’s MHRA

Kineret (anakinra), from Nordic biotech firm Swedish Orphan Biovitrum (STO: SOBI), has been licensed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for children and babies from eight months old with cryopyrin-associated periodic syndromes (CAPS).

CAPS is an umbrella term for a number of ultra-rare, life-long, severely debilitating autoinflammatory diseases which cause rash, headache, fever, joint pain and other inflammatory symptoms. It affects around one in one million people in the UK and patients suffer substantial pain and progressive reduction in their quality of life. The most severe form of the condition causes chronic inflammation of the meninges (aseptic meningitis).

The company said patients choosing Kineret will be able to have their therapy managed at home with daily injections, monitored by their local specialist. To facilitate use in pediatric patients, the new license requires use of a syringe with marked graduations to allow for dose adjustments. It is anticipated that this graduated syringe will be available in spring 2014.