The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Kineret (anakinra) to treat certain patients with COVID-19.

The authorization pertains to hospitalized patients who have positive results of direct SARS-CoV-2 viral testing, have pneumonia requiring supplemental oxygen (low- or high-flow oxygen), are at risk of progressing to severe respiratory failure, and are likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR).

Anakinra is an interleukin-1 (IL-1) receptor antagonist. IL-1 is involved in inflammatory diseases and has been linked to acute severe lung inflammation in COVID-19.

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The emergency authorization was supported by data from the phase 3 SAVE-MORE trial ( Identifier: NCT04680949), which was designed to evaluate the efficacy and safety of anakinra in adults with COVID-19 pneumonia who were at risk of developing severe respiratory failure. All enrolled patients were required to have a plasma suPAR level of at least 6 ng/mL.

Patients were randomly assigned 2:1 to receive anakinra at 100 mg subcutaneously once daily (n=405) or placebo (n=189) for 10 days, in addition to standard care. The primary endpoint of the study was a comparison of the 2 treatment arms at day 28 using the 11-point WHO Clinical Progression Scale.

Treatment with anakinra was associated with lower odds of more severe disease at day 28 compared with placebo (odds ratio, 0.37; 95% CI, 0.26-0.50). By day 28, there were 86 patients (21.2%) in the anakinra arm and 62 patients (32.8%) in the placebo arm who developed severe respiratory failure (HR, 0.66; 95% CI, 0.48-0.92; risk difference, -11.6%; 95% CI, -19.4, -3.8).

By day 28, there were 13 deaths (3.2%) in the anakinra arm and 13 deaths (6.9%) in the placebo arm (hazard ratio [HR], 0.48; 95% CI, 0.22-1.04; risk difference, -3.7%; 95% CI, -7.7, 0.3). By day 60, there were 21 deaths (5.3%) in the anakinra arm and 18 deaths (9.7%) in the placebo arm (HR, 0.56; 95% CI, 0.30-1.04; risk difference, -4.4% [95% CI, -9.2, 0.4]).

The most common adverse reactions reported with anakinra were increased transaminases, neutropenia, rash, and injection site reactions.

For the treatment of adults with COVID-19, the recommended dose of Kineret is 100 mg administered daily by subcutaneous injection for 10 days. Dosage adjustment should be considered in patients with severe renal insufficiency or end-stage renal disease. Kineret is supplied in a single-use prefilled syringe.


Fact sheet for healthcare providers: Emergency use authorization for Kineret. Swedish Orphan Biovitrum AB. Accessed November 9, 2022.

This article originally appeared on MPR