FDA Issues EUA for Kineret for Hospitalized COVID-19 Patients

FDA has issued an emergency use authorization (EUA) for Sobi’s Kineret (anakinra) injection for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure.

Kineret is an Interleukin-1 (IL-1) receptor antagonist. IL-1 is involved in inflammatory diseases and IL-1 is linked to acute severe lung inflammation in COVID-19. Kineret is currently FDA-approved to treat patients with rheumatoid arthritis; cryopyrin-associated periodic syndromes, a rare, hereditary inflammatory disorder; and deficiency of IL-1 receptor antagonist, a rare life-threatening autoinflammatory disease.

The EUA was based on data from the SAVE-MORE trial of adult patients with COVID-19 pneumonia who were at risk of developing severe respiratory failure. The trial enrolled 594 patients; 189 patients were randomized to the placebo plus standard of care arm and 405 patients to the Kineret plus standard of care arm for 10 days. At the start of treatment, 91% of patients had severe COVID-19 pneumonia and required low- or high- flow supplementary oxygen.

Patients treated with Kineret had lower odds of more severe disease according to the WHO Clinical Progression ordinal Scale at day 28 compared with placebo. By day 28, there were 13 deaths (6.9%) in the placebo arm and 13 deaths (3.2%) in the Kineret. By day 60, there were 18 deaths (9.7%) in the placebo arm and 21 deaths (5.3%) in the Kineret arm. The most common adverse reactions with use of Kineret are elevated liver enzymes, neutropenia, rash, and injection site reactions. Kineret has been associated with an increase of serious infections in patients with rheumatoid arthritis.