The Center for Drug Evaluation (CDE) website indicates that Swedish Orphan Biovitrum AB’s (Sobi; BMV: SOBIN) market filing for its anakinra (trade name: Kineret) has been prioritized for review. The drug is indicated for autoinflammatory periodic fever syndrome (familial Mediterranean fever – FMF) in adults, adolescents, children, and infants eight months of age and older (weight 10 kg and over), for use in combination with colchicine if applicable.
Drug Background
Anakinra, a human interleukin – 1 (IL – 1) receptor antagonist originated by Sobi, was first approved in the US to treat rheumatoid arthritis (RA) in 2001. It has since received additional indications for cryptographic protein – associated periodic syndrome (CAPS), neonatal polyinflammatory disease (NOMID), and early – onset NOMID in children and adults. It is the first and only FDA – approved NOMID therapy.
Clinical Trials and Pediatric Drug Development
Anakinra is subject to an investigator – initiated trial (ITT) in China and was included on the third list of pediatric drugs encouraged for development in August 2018. The revised Drug Administration Law promotes the research and development of pediatric drugs, as well as the development of new varieties, dosage forms, and specifications tailored to children’s physical characteristics. Such drug products are eligible for priority reviews.
About FMF
FMF, an inherited autoinflammatory disease characterized by recurrent episodes of fever and serositis, was first reported in 1947. The causative gene MEFV of FMF, located on chromosome 16p13.3, was first confirmed in 1992. It is currently believed that 10% to 20% of patients who meet clinical diagnostic criteria do not carry any genetic mutation known to cause FMF. China reported its first FMF case in 1999 at the Fudan University Affiliated Children’s Hospital.-Fineline Info & Tech
