The Committee for Medicinal Products for Human Use of the EMA has adopted a positive opinion of Kineret for the treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor ≥ 6ng/ml.
EMA has recommended approval for use of Kineret in COVID-19 to the European Commission which will issue a final decision, states the company.
“At a time when many countries still face enormous pressure as they continue to care for extremely ill patients, today’s positive opinion from the CHMP represents an important milestone for the treatment of COVID-19. If approved by the European Commission, this will be welcome news for many across Europe,” says Ravi Rao, Head of Research & Development and Chief Medical Officer at Sobi.
Based on results from the SAVE-MORE phase 3 study
The positive opinion is based on results from the SAVE-MORE phase 3 study which found that early identification of candidate patients with suPAR followed by treatment with anakinra resulted in a 64% relative reduction of patients progressing into severe disease and death, in a 55% relative decrease in mortality, which reached 80% relative decrease in mortality for patients with cytokine storm. Results were published in Nature Medicine on 3 September 2021.
The SAVE-MORE study used learning from previous trials and demonstrated the effectiveness of anakinra therapy in patients who had not yet progressed to severe respiratory failure but had poor prognosis, identified by a plasma biomarker of inflammation.
“I would like to congratulate Professor Giamarellos-Bourboulis and his collaborators for conducting this impressive work under such challenging conditions. We look forward to ongoing dialogue with other regulatory agencies to ensure anakinra is available to patients with COVID-19 pneumonia,” says Guido Oelkers, CEO of Sobi.
Photo of Ravi Rao: Sobi