New FDA Approvals: FDA Issues Emergency Use Authorization to Kineret
Nov. 9: The FDA issued an emergency use authorization to Amgen Inc.’s Kineret (anakinra) for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). The agency initially approved the interleukin-1 receptor antagonist (IL-1Ra) on Nov. 14, 2001. The recommended dosing for this latest use is 100 mg administered daily by subcutaneous injection for 10 days. Drugs.com lists the price of one 100 mg prefilled syringe as more than $1,265.
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