The authorisation was based on findings of the SAVE-MORE phase 3 study which showed long-term benefits with improved outcomes, reduced progression to respiratory failure and mortality in patients
Sobi has received EUA from FDA for the use of Kineret in the treatment of COVID-19 related pneumonia in hospitalised patients. (Credit: Swedish Orphan Biovitrum AB)
Sobi has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the use of its arthritis drug Kineret (anakinra) in the treatment of COVID-19 related pneumonia.
The EUA is for hospitalised COVID-19 patients with pneumonia who need supplemental oxygen (low- or high-flow oxygen) and who could progress to severe respiratory failure.
FDA granted the authorisation based on findings of the SAVE-MORE phase 3 study in hospitalised with COVID-19 pneumonia needing supplemental oxygen. The late-stage trial showed long-term benefits with improved outcomes, and reduced progression to respiratory failure and mortality in patients.
The phase 3 double-blind randomised controlled trial enrolled 606 patients across 40 sites in Italy and Greece.
Sobi chief medical officer and research and development head Anders Ullman said: “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.”
Kineret is already approved by the European Union for treating COVID-19 in adults with pneumonia who need oxygen support and are at risk of developing severe respiratory failure.
The anti-inflammatory drug is designed to block the biological activity of the cytokines IL-1α and β, which are involved in COVID19-induced hyperinflammation.
In July this year, the Sobi signed an agreement with Swiss biotechnology firm ADC Therapeutics to develop and market Zynlonta drug for all hematologic and solid tumour indications. outside of the US, Greater China, Singapore, and Japan.