Humanigen initiated submission for lenzilumab Marketing Authorization in COVID-19, to United Kingdomメs MHRA

On Jun. 14, 2021 Humanigen announced it had initiated a rolling review submission for Marketing Authorization (MA) by the MHRA for its lead drug candidate, lenzilumab.

In the LIVE-AIR phase 3 clinical trial, lenzilumab achieved the primary endpoint with a 54% relative improvement in the likelihood of survival without ventilation (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.

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Source: Humanigen
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