December 22, 2020

The U.S. FDA has approved a new indication for Kineret® (anakinra), manufactured by Sobi. The drug is now indicated to treat deficiency of IL-1 receptor antagonist (DIRA).

An ultra-rare inflammatory disease, DIRA occurs when there is a mutation in the IL1RN gene. This gene is responsible for controlling production of interleukin-1 receptor antagonist (IL-1Ra) protein, which is needed to control the body’s inflammatory response. Without this protein, life-threatening inflammation can occur throughout the body, involving both the skin and bones. Symptoms can manifest as early as the first weeks following birth.

Approval of the new indication is based on the results of a long-term natural history study, in which nine patients with genetically confirmed DIRA received Kineret for up to 10 years. Patients were one month to nine years of age at the start of treatment, and all achieved inflammatory remission while on Kineret. Inflammatory remission was defined as achievement of all three of the following criteria: C-reactive protein (CRP) serum levels (a measure of inflammation in the body) less than or equal to 5mg/L; no pustulosis (an inflammatory skin condition); no inflammatory bone disease; and no concomitant use of glucocorticosteroid (a type of anti-inflammatory medication).

Recommended initial dosing under the new indication is 1-2mg/kg of body weight, administered once daily as a subcutaneous injection. The dose should be individually adjusted as needed to control active inflammation, up to a maximum daily dose of 8mg/kg. Dose adjustment may be necessary for patients who have severe renal insufficiency or end stage renal disease.

First FDA approved in 2001, Kineret is also indicated to treat rheumatoid arthritis and neonatal-onset multisystem inflammatory disease.

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