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KB 003 filed with FDA requesting EUA for COVID-19.- Humanigen

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Published:30th May 2021
Humanigen announced that the company submitted an application to the FDA requesting Emergency Use Authorization (EUA) for KB 003 (lenzilumab) for the treatment of patients hospitalized with COVID-19.

This EUA application follows positive results from the LIVE-AIR Phase III clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation (SWOV) in newly hospitalized COVID-19 patients.Lenzilumab achieved the primary endpoint with a 54% relative improvement in the likelihood of SWOV compared to placebo. Lenzilumab also improved the relative likelihood of SWOV by 92% in subjects who received both corticosteroids and remdesivir and resulted in a 3-fold improvement in the likelihood of SWOV in patients with a CRP<150 mg l and less than 85 years of age. in these patients, a 2.2-fold improvement in the likelihood of survival was observed with lenzilumab. no serious adverse events were attributed to lenzilumab and the overall safety profile was comparable to placebo.></150>

Condition: Coronavirus/COVID-19 Infection
Type: drug

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