FDA grants Emergency Use Authorisation for Kineret for treatment of COVID 19 patients with pneumonia
Sobi announced that the FDA 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
Kineret is an anti-inflammatory medicine that neutralises the biological activity of both cytokines IL-1alpha and beta, which play a role in COVID19-induced hyperinflammation. Blocking these cytokines early in the course of the hyperinflammatory phase can have an important impact on COVID-19 disease progression.
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. The authorisation was based on results from the SAVE-MORE phase III study which were published in Nature Medicine on 3 September 2021.
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