FDA issues emergency use authorization for anakinra to treat COVID-19
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The FDA has issued an emergency use authorization for anakinra injection in the treatment of COVID-19 among hospitalized adults with pneumonia requiring supplemental oxygen.
According to a statement from the FDA, the EUA is specifically for adult patients hospitalized with pneumonia requiring supplemental oxygen who are at risk for progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor.
The decision is based on the “totality of scientific evidence available to FDA,” read the statement, including data from the clinical trial SAVE-MORE, a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of anakinra (Kineret, SOBI) in adult patients with COVID-19 pneumonia who were at risk of developing severe respiratory failure.
According to the FDA, it is “reasonable to believe that Kineret may be effective” for the treatment of COVID-19 in these adults.
Anakinra is currently approved by the FDA for rheumatoid arthritis, cryopyrin-associated periodic syndromes and deficiency of interleukin-1 receptor antagonist. It is also used as an off-label treatment for gout.
The most common adverse reactions identified with use of anakinra are elevated liver enzymes, neutropenia, rash and injection site reactions, according to the FDA. The drug has additionally been associated with an increase in serious infections among patients with RA.
Full safety information, dosing instructions and potential side effects can be found in the EUA Fact Sheet for Health Care Providers.
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