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Humanigen submits all planned modules of lenzilumab for potential conditional marketing authorization in hospitalized COVID-19 patients to the UK’s MHRA.

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Last updated:8th Oct 2021
Published:6th Oct 2021
Humanigen, Inc. announced it has submitted all the planned modules as well as a risk management plan and pediatric investigation plan for the lenzilumab Conditional Marketing Authorization (CMA) in hospitalized COVID-19 patients to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

MHRA has previously accepted the application for expedited COVID-19 rolling review.

The LIVE-AIR study achieved its primary endpoint of SWOV ( improved survival without ventilation), or measured through day 28 following treatment (HR: 1.54; 95%CI: 1.02-2.32, p=0.0403). The Kaplan-Meier estimate for IMV and/or death was 15.6% (95%CI: 11.5-20.9) in the lenzilumab arm versus 22.1% (95%CI: 17.4-27.9) in the placebo arm. Approximately 94% of patients received dexamethasone (or other steroids), 72% received remdesivir, and 69% received both. In this study, lenzilumab appeared to be safe and well-tolerated, there were no serious adverse events (SAEs) attributed to lenzilumab and no suspected unexpected serious adverse reactions (SUSARS) reported for lenzilumab. No SAEs have been attributed to lenzilumab in four completed studies across multiple indications. Results of LIVE-AIR have been submitted for publication in a peer-reviewed journal.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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