Sobi announced that the US Food and Drug Administration has granted Emergency Use Authorisation (EUA) for the use of Kineret (anakinra) for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure.
COVID-19 can progress to severe respiratory failure and death due to an excessive inflammatory response 1. Kineret is an anti-inflammatory medicine that neutralises the biological activity of both cytokines IL-1α and β, which play a role in COVID19-induced hyperinflammation2. Blocking these cytokines early in the course of the hyperinflammatory phase can have an important impact on COVID-19 disease progression3.
Kineret was shown to improve outcomes, reduce progression to severe respiratory failure and mortality in patients hospitalised with COVID-19 pneumonia requiring supplemental oxygen, and the benefits were maintained long-term.
“This is another important milestone for Sobi. The authorisation will provide both patients and treating physicians in the US with a treatment option against COVID-19 related pneumonia,” said Anders Ullman, Head of Research & Development and Chief Medical Officer at Sobi.
The authorisation was based on results from the SAVE-MORE phase 3 study which were published in Nature Medicine on 3 September 2021.