FDA nod for Kineret injection for use as COVID-19 treatment

The US Food and Drug Administration (FDA) yesterday issued an  emergency use authorization (EUA)for Kineret (anakinra) injection for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR).

Marketed by Swedish Orphan Biovitrum (STO: SOBI), also known as Sobi, Kineret has been authorized in the European Union since March 2002 for the treatment of a number of inflammatory conditions. Kineret is also currently FDA-approved for treatment of rheumatoid arthritis, cryopyrin-associated periodic syndromes, and deficiency of interleukin (IL)-1 receptor antagonist.

“This is another important milestone for Sobi. The authorization will provide both patients and treating physicians in the US with a treatment option against COVID-19 related pneumonia,” said Anders Ullman, head of R&D and chief medical officer at Sobi.