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Sobi’s Kineret granted FDA Emergency Use Authorisation for COVID-19 related pneumonia

The IL-Ra1 inhibitor was found to reduce the risk of disease progression by 64%


Sobi’s Kineret (anakinra) has been granted Emergency Use Authorisation (EUA) by the US Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalised adults with pneumonia requiring supplemental oxygen who are at risk for progressing to severe respiratory failure.

Kineret is an anti-inflammatory medicine that neutralises the biological activity of both cytokines IL-1α and β, which play a role in COVID19-induced hyperinflammation. Blocking these cytokines early in the course of the hyperinflammatory phase can have an important impact on COVID-19 disease progression, the company explained.

The FDA’s decision was based on positive results from the SAVE-MORE phase 3 trial which evaluated the safety and efficacy of a 100mg subcutaneous daily dose of Kineret for up to ten days.

The study found that early treatment of COVID-19-hospitalised patients with Kineret showed considerable efficacy and reduced the risk of disease progression by 64%.

Treatment with Kineret was also shown to reduce the risk of severe disease by 54% and the average time until hospital and intensive care unit discharge was reduced by one and four days.

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

The drug has already been on the US market for more than two decades for the treatment of rheumatoid arthritis, and has been indicated for a variety of other inflammatory conditions over the years, including neonatal-onset multisystem inflammatory disease, which is a form of cryopyrin-associated periodic syndromes.

Kineret has already been granted approval for COVID-19 related pneumonia in the EU, where it is also indicated in adults for the treatment of rheumatoid arthritis in combination with methotrexate, as well as a variety of inflammatory conditions.

With the authorisation, Kineret joins a number of other rheumatoid arthritis drugs repurposed for COVID-19 patients on oxygen. This includes Roche’s Actemra (tocilizumab), which was granted EUA by the FDA in June 2021 to be used alongside corticosteroids for hospitalised patients requiring oxygen support.

Eli Lilly and Incyte’s Olumiant (baricitinib) was also approved for emergency use in the US in May 2022, making it the first FDA-approved Janus kinase inhibitor for the treatment of hospitalised COVID-19 patients.

Article by
Emily Kimber

11th November 2022

From: Regulatory, Healthcare



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