In a significant move to combat the ongoing COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has updated the Emergency Use Authorization (EUA) for Kineret, an Interleukin-1 (IL-1) receptor antagonist. This decision comes after careful evaluation and consideration of scientific evidence, including data from the clinical trial SAVE-MORE (NCT04680949).
On February 4, 2020, recognizing the severity of the public health emergency posed by the virus causing COVID-19, the Secretary of the Department of Health and Human Services (HHS) determined the need for emergency use authorizations. Subsequently, on March 27, 2020, the Secretary declared the circumstances justifying the emergency use of drugs and biological products, leading to the current update.
Kineret, approved by the FDA for various indications, has not been previously authorized for treating COVID-19. However, the recent evaluation, considering the data from the SAVE-MORE trial, has led to the conclusion that Kineret may be effective in treating COVID-19 in specific hospitalized adults. These individuals must have positive results of direct SARS-CoV-2 viral testing, pneumonia requiring supplemental oxygen (low- or high-flow oxygen), and are at risk of progressing to severe respiratory failure with likely elevated plasma soluble urokinase plasminogen activator receptor (suPAR).
The FDA emphasizes that the known and potential benefits of Kineret, when used under these specific conditions, outweigh the known and potential risks. The decision is rooted in the absence of adequate approved alternatives for the emergency use of Kineret in treating COVID-19 in the described patient population.
The scope of authorization, outlined by the FDA, limits the use of Kineret to healthcare providers treating hospitalized adults meeting the specified criteria. Kineret will be administered via subcutaneous injection, and the authorized storage and handling information can be found in the official Fact Sheets.
Sobi, the pharmaceutical company behind Kineret, will play a crucial role in ensuring the distribution of the authorized drug and accompanying Fact Sheets. The FDA has set forth stringent conditions for Sobi and authorized distributors to comply with, including reporting of adverse events, adherence to manufacturing standards, and providing necessary information for ongoing evaluations.
The FDA’s authorization is effective until the declaration justifying the emergency use of drugs during the COVID-19 pandemic is terminated or the EUA is revoked. The Agency will closely monitor the implementation and impact of this authorization, emphasizing the importance of compliance with the specified conditions.
This update marks a significant step in expanding treatment options for COVID-19 and reflects the FDA’s commitment to utilizing available resources to address the ongoing public health crisis.