On 16 June, 2020 FDA has approved canakinumab for the treatment of active Still disease and adult-onset Still disease (AOSD). The medicine is to be supplied in single-dose vials as 150 mg lyophilized powder for reconstitution plus 150 mg/mL solution for SC injection.

AOSD is an uncommon systemic inflammatory illness marked by arthritis, fever, rash and raised inflammatory markers. Although the exact cause of disease is unspecified, but it is supposed to be closely connected with systemic juvenile idiopathic arthritis (SJIA). With respect to AOSD, canakinumab works by binding to human IL1β and hindering its interaction with IL-1 receptors, thus suppressing inflammation.

In terms of safety, most common adverse reactions concerning canakinumab in AOSD patients were infections i.e. nasopharyngitis and upper RTI, abdominal pain, and injection site reactions.

As per Nikolay Nikolov, acting director of Division of Rheumatology and Transplant Medicine in FDA’s Center for Drug Evaluation and Research, “Preceding the approval, patients had no FDA-approved therapies for their ailment, with symptoms for example, rash, painful arthritis and fevers. Canakinumab was already approved for SJIA treatment on May, 2013 in patients aged 2 years and more.