FDA Grants Sobi Emergency Authorization for Kineret to Treat COVID-19
The FDA has granted Sobi’s Kineret (anakinra) Emergency Use Authorization (EUA) for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure.
Kineret is an anti-inflammatory medicine that neutralizes the activity of two types of cytokines associated with inflammatory responses. Blocking the cytokines can have an impact on disease progression, the company said.
The EUA was based on positive results from a phase 3 study which concluded that early treatment with Kineret for patients hospitalized with moderate and severe COVID-19 significantly reduced the risk of a worse clinical outcome at day 28.
Kineret is also authorized in the EU for use in adults with COVID-19 and pneumonia requiring supplemental oxygen who are at risk of developing severe respiratory failure.