EMA recommends approval for use of Kineret in COVID-19 to the European Commission

EMA’s human medicines committee (CHMP) has recommended extending the indication of Kineret (anakinra) to include treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least 6 ng per ml.

Kineret, marketed by Swedish Orphan Biovitrum AB (publ), is an immunosuppressive medicine (meaning it reduces the activity of the immune system). It is currently authorised in the EU for the treatment of various inflammatory conditions. In COVID-19 patients, the medicine is considered to reduce the inflammation associated with COVID-19 and thus decrease lower airway damage, preventing development of severe respiratory failure.

“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.

Study data in COVID-19

In reaching its conclusion, the CHMP evaluated data from a study involving 606 hospitalised adults with moderate or severe COVID-19 pneumonia and who had suPAR levels of at least 6 ng per ml. These patients received Kineret or placebo (a dummy treatment) by injection under the skin in addition to standard of care. Standard of care for most patients included low or high flow oxygen and the corticosteroid medicine dexamethasone, and some also received remdesivir.

The study showed greater clinical symptom improvements in patients treated with Kineret plus standard of care compared with those who received placebo plus standard of care. Kineret reduced the risk of a patient’s condition worsening to more severe disease or death during the 28-day study period compared with placebo. The treatment benefit of Kineret compared to placebo was supported by an increase in the number of patients who fully recovered and a reduction in the number of patients whose condition worsened to severe respiratory failure or death.

The study also indicated that Kineret’s safety in patients with COVID-19 was similar to that seen in patients treated for the other approved indications. As such, the CHMP concluded that the medicine’s benefits are greater than the risks for patients like those studied in this clinical trial. Efficacy of Kineret has not been shown in patients requiring non-invasive or mechanical ventilation or extracorporeal membrane oxygenation (a heart-lung bypass life support system).