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Humanigen Aims For New EUA Request After FDA Turns Down Lenzilumab

The company plans to make a new EUA request prior to filing a BLA, but does not yet have a specific timeline. Meanwhile, it has been preparing for the drug’s distribution as a COVID-19 treatment.

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In a surprising move, the US Food and Drug Administration has turned down Humanigen, Inc.’s request for an emergency use authorization for lenzilumab as a prevention and treatment for cytokine storm in patients newly hospitalized with COVID-19. However, the company is likely to be able to provide the additional data the agency requested and has also been hard at work setting the drug up for distribution under an EUA.

The Burlingame, CA-based firm said on 9 September that the FDA had declined its request for an EUA, stating in...

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