The Committee for Medicinal Products for Human Use (CHMP) of the EMA (European Medicines Agency) expressed positive opinion for using Kineret® (anakinra) for the treatment of adult COVID-19 patients with pneumonia who require supplemental oxygen (low or high flow oxygen) and who are at risk of progressing to severe respiratory failure determined by plasma concentration of the soluble plasminogen activating urokinase receptor (suPAR) ≥ 6ng / ml. EMA has recommended Kineret’s approval for the treatment of COVID-19 to the European Commission which will issue a final decision.
COVID-19 infection can lead to death from one inflammatory response excess of the infected person, often referred to as a “cytokine storm”i. Anakinra is an anti-inflammatory therapy that acts on IL-1α / β cytokines, which play a role in COVID-19-induced hyperinflammation. Blockade of IL-1α / β cytokines before the hyperinflammatory phase can greatly influence the progression of COVID-19ii.
The positive opinion is based on the results (published in Nature Medicine on September 3, 2021) of the ‘Save More’ phase 3 study according to which the early identification of candidate patients with suPAR followed by treatment with anakinra led to a reduction of 64% of patients progressing to severe disease and death, a 55% decrease in mortality, which reached an 80% decrease in mortality for cytokine storm patients.
The SAVE-MORE study used data from previous studies and demonstrated the efficacy of the therapy with anakinra in patients who had not yet progressed to severe respiratory failure but had a poor prognosis, identified by a plasma biomarker of inflammation.
“I would like to thank all the collaborators, patients and their relatives who contributed to the advancement of science and the treatment of COVID patients with adequate care during the SAVE-MORE study” – stated the Principal Investigator, Evangelos J. Giamarellos-Bourboulis, Professor at the National and Kapodistrian University of Athens and President of the Hellenic Institute for the Study of Sepsis.
“Almost two years after the start of the COVID-19 pandemic, the urgency to contain and treat the virus as effectively and safely as possible is still a reality. In this scenario, the positive opinion expressed by the CHMP for the use of anakinra represents the first step that we hope will soon lead to the official approval by EMA “ – holds Sergio Lai, Vice President and General Manager di Sobi Italy, Greece, Malta and Cyprus.
About Kineret® (anakinra)
Kineret® is an interleukin-1 α and β receptor antagonist that has gained indications in the United States for the treatment of signs and symptoms and slowing the progression of structural damage in moderate to severe active rheumatoid arthritis in adult patients who have failed to respond to one or more disease-modifying antirheumatic therapies (DMARDs), for the treatment of neonatal-onset multisystem inflammatory disease (NOMID, a form of cryopyrin-associated periodic syndrome or CAPS), and for the treatment of Interleukin-1 receptor antagonist (DIRA).
In Europe, Kineret was indicated for the treatment of rheumatoid arthritis (RA) signs and symptoms in combination with methotrexate in adults who have an inadequate response to methotrexate alone.