Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), announced that the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for KINERET® (anakinra) for the treatment of Coronavirus Disease 2019 (COVID-19) in adult patients who are hospitalized with positive results of direct SARS-CoV-2 viral testing with pneumonia, requiring supplemental oxygen (low- or high-flow oxygen), and are at risk of progressing to severe respiratory failure, and are likely to have an increased blood level of a certain substance called urokinase plasminogen activator receptor (suPAR) that may be a sign of increased risk of worsening of the disease. The decision is based on results from the SAVE-MORE phase 3 study, which was the first large, pivotal randomized controlled trial to specifically evaluate a COVID-19 patient population at risk of progressing to critical state and demonstrate considerable benefit of earlier intervention for the prevention of disease progression and death. The study, conducted by the Hellenic Institute for the Study of Sepsis, found that early treatment of COVID-19-hospitalized patients with KINERET showed considerable efficacy, and reduced the risk of disease progression by 64 percent.

In addition, treatment with KINERET reduced the risk of severe disease or death by 54 percent. Results were published in Nature Medicine on Sept. 3, 2021.

COVID-19 infection may lead to respiratory failure or death due to an overreaction of the infected person's inflammatory response. KINERET blocks the biologic activity of IL-1 alpha and beta by competitively inhibiting IL-1 binding to the interleukin-1 type I receptor (IL-1RI), which is expressed in a wide variety of tissues and organs. Early treatment before the hyperinflammatory phase can have a significant impact on COVID-19 disease progression.

The emergency use of KINERET for COVID-19-related pneumonia has not been approved or licensed by the FDA, but has been authorized by the FDA under an EUA for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the U.S. Food Drug and Cosmetic Act, unless the declaration is terminated or authorization revoked sooner.