Kineret receives positive CHMP opinion for treatment of COVID-19 pneumonia

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of Kineret (anakinra), a treatment for coronavirus disease in adult patients with pneumonia. The drug – by Swedish Orphan Biovitrum AB (Sobi) – is for patients with diseases requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure.

The positive opinion of the CHMP is based on results from the SAVE-MORE phase 3 clinical study, which found that early identification of candidate patients with soluble urokinase plasminogen activator receptor (suPAR), followed by treatment with anakinra, resulted in a 64% relative reduction of patients progressing into severe disease and death.

The study also saw a 55% relative decrease in mortality, which reached 80% relative decrease in mortality for patients with cytokine storm. COVID-19 infection can lead to death due to an overreaction of the infected person’s inflammatory response, often referred to as a ‘cytokine storm’. Anakinra is an anti-inflammatory therapy that works by targeting the cytokines IL-1α/β, which contribute to COVID-19-induced hyperinflammation. Blocking this cytokine can therefore have an important impact on COVID-19 disease progression.

The SAVE-MORE study utilised learning from previous trials and demonstrated the efficacy of anakinra therapy in patients who had not yet progressed to severe respiratory failure, but who had a poor prognosis. This was identified by a plasma biomarker of inflammation.

“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,” said Ravi Rao, head of research & development and chief medical officer at Sobi.