Humanigen seeks EUA from USFDA for Lenzilumab to treat COVID-19

Humanigen announced that the company submitted an application to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for lenzilumab for the treatment of patients hospitalised with COVID-19. This EUA application follows positive results from the LIVE-AIR Phase 3 clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation (SWOV) in newly hospitalized COVID-19 patients.

“Filing for EUA in the US is a critical step to making a therapeutic option available for COVID-19,” said Cameron Durrant, CEO, Humanigen. “There is a need for therapies for hospitalized patients who require supplementary oxygen. Treatments can be lifesaving; despite vaccinations, infections and significant breakthrough disease will continue. Lenzilumab, should the FDA grant authorization, can address a critical unmet need for an effective treatment. We are extremely grateful to the investigative team and volunteers in the clinical trial program, as their involvement was vital in delivering this positive Phase 3 study.”

Lenzilumab achieved the primary endpoint with a 54 per cent relative improvement in the likelihood of SWOV compared to placebo. Lenzilumab also improved the relative likelihood of SWOV by 92 per cent in subjects who received both corticosteroids and remdesivir and resulted in a three-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.