Kineret authorised for emergency use by FDA for the treatment of COVID-19 related pneumonia

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.