FDA Authorizes Emergency Use of Kineret for Certain Hospitalized COVID-19 Patients

Kineret is an interleukin-1 receptor antagonist.

The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Kineret (anakinra) for the treatment of COVID-19 in hospitalized patients with positive results of direct SARS-CoV-2 viral testing with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and 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. The emergency authorization was supported by data from the phase 3 SAVE-MORE trial (ClinicalTrials.gov Identifier: NCT04680949), which evaluated 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 6ng/mL.

Patients were randomly assigned 2:1 to receive either anakinra 100mg subcutaneously once daily (n=405) or placebo (n=189) for 10 days, in addition to standard of 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 ordinal Scale.

Results showed that 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). 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 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 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 100mg 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. https://www.fda.gov/media/163075/download