FDA declines to grant emergency use authorization of lenzilumab to treat newly hospitalized COVID-19 patients.
In its letter, FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19.
The company said the National Institute of Allergy and Infectious Diseases-sponsored ACTIV-5 Big Effect Trial (BET-B) – a placebo-controlled study testing lenzilumab with Gilead Sciences, Inc.’s Veklury (remdesivir) – has increased its enrollment target from 400 to 500, and Humanigen expects that the study may provide additional safety and efficacy data to support a new EUA request.
The Company hopes that data from ACTIV-5/BET-B – which currently has 300 patients enrolled – will become available by the end of the year, and it plans to submit a biologics license application at the beginning of 2022. It was unable to provide an exact timeline for when the new EUA request would happen, but said it would “definitely” come before the BLA.
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