Kineret (Anakinra) For The Treatment Of COVID-19-Associated Pneumonia Expands Its Immunomodulatory Applications
The U.S. Food and Drug Administration (FDA) has expanded its approval of Sobi’s (Swedish Orphan Biovitrum AB) Kineret® (anakinra) for the treatment of patients with pneumonia caused by COVID-19, especially those at risk of progression to severe respiratory failure.
This decision, based on positive data from the SAVE-MORE clinical trial, further strengthens Kineret’s position as a key immunomodulatory drug.
Kineret’s Mechanism Of Action And Current Indications
Kineret is a recombinant human interleukin-1 receptor antagonist (IL-1Ra) that attenuates the inflammatory response by competitively inhibiting the binding of IL-1α and IL-1β to their receptors and blocking pro-inflammatory signaling.
Originally approved for the treatment of rheumatoid arthritis (RA) in 2001, the drug has since been expanded to include a number of rare autoinflammatory diseases, including:
Neonatal Multisystem Inflammatory Disease (NOMID) – the most severe subtype of CAPS (Cold Pyridoxine-Associated Periodic Syndrome).
Interleukin-1 receptor antagonist deficiency (DIRA) – a rare inherited autoinflammatory disease.
Familial Mediterranean fever (FMF) – approved in China in October 2023 for adult and pediatric patients.
Clinical Rationale For The COVID-19 Indication
The FDA’s Emergency Use Authorization (EUA) was based on data from the SAVE-MORE trial, which enrolled 594 patients with COVID-19 pneumonia, and showed that:
A 64% reduction in the risk of disease progression at day 28 in the Kineret treatment group (OR 0.36, 95% CI 0.26-0.49).
Risk of serious illness or death was reduced by 54% (OR 0.46, 95% CI 0.26-0.83).
Patients had a 1-day shorter mean hospital stay and a reduced need for intensive care.
The recommended dose is 100 mg subcutaneously daily for 10 days, which may be adjusted to alternate-day dosing in patients with renal insufficiency.
Market Performance And Future Outlook
Kineret, one of Sobi’s core products, has been expanding its indications in recent years, driving its global market growth.
In 2023, the drug was approved for the FMF indication in China, further expanding its application in the Asia-Pacific region.
In addition, Sobi is exploring the potential of Kineret in other inflammatory diseases such as Still’s disease and macrophage activation syndrome (MAS).
However, safety risks of Kineret remain a concern, including increased risk of infection, neutropenia and injection site reactions.
Physicians need to weigh the benefits of treatment against the potential risks, especially in immunocompromised patients.
Conclusion
The approval of Kineret’s COVID-19 indication marks an important advance in the field of immunomodulation, providing a new treatment option for patients with severe pneumonia.
With further research, the drug may play a role in more inflammatory diseases, further cementing its place in the treatment of rare diseases and severe infections.
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