Humanigen Initiates Submission for Lenzilumab Marketing Authorization in COVID-19, to the United Kingdom’s MHRA

Humanigen, Inc. a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’, announced it has initiated a rolling review submission for Marketing Authorization (MA) by the MHRA for its lead drug candidate, lenzilumab. This application follows Humanigen’s submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA).

“We are excited about this submission and are pleased with the collaborative discussions we have had with the MHRA regarding the potential of this MA to be recognized as a Conditional Marketing Authorization Application (CMA),” said Cameron Durrant, MBA, MD, CEO of Humanigen. “Despite vaccine uptake, there continues to be a need for proven therapies that are variant-agnostic for patients that remain at risk of COVID-19. Now, with applications in the US and in the UK, we feel we can help tackle this global challenge. We hope to provide a powerful solution for hospitalized patients on both sides of the Atlantic. Following the LIVE-AIR clinical study results, we strongly believe that lenzilumab can improve patient outcomes. We are pleased to be able to submit this application through Humanigen Ltd., our wholly-owned UK subsidiary. This is a pivotal step in the evolution of our company as we prepare to bring our first drug to market.”

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. 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.

“It is amazing to see what targeted treatments can do when their use can be properly characterized as we observed in the LIVE-AIR clinical trial,” said Vincent Marconi, MD, Professor of Medicine at Emory University School of Medicine. “We are pleased to be part of the effort that might provide physicians in multiple countries with lenzilumab for the treatment of hospitalized COVID-19 patients. At Emory University, a key center in the National Institutes of Health (NIH) ACTIV-5 study in which lenzilumab is included, we hope to provide further valuable support for any benefits of lenzilumab.”