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Humanigen gets positive feedback from FDA ahead of emergency use application for coronavirus drug lenzilumab

The agency said no material changes are needed in the company’s chemistry, manufacturing & controls plan, EUA labeling and the statistical analysis plan

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Lenzilumab is designed to treat what is known as the cytokine storm, an overactive immune response to conditions such as COVID-19 that can cause inflammation, fatigue and, in severe cases, organ failure

Humanigen Inc (NASDAQ:HGEN) announced Friday that the US Food and Drug Administration said its Emergency Use Authorization (EUA) application for its coronavirus treatment lenzilumab may be sufficient, pending Phase 3 trial data.

The agency provided feedback at what is known as a type B meeting, and said that no material changes are needed in the company’s chemistry, manufacturing & controls plan, EUA labeling and the statistical analysis plan.

“FDA was very helpful and provided clear guidance on our EUA submission plan,” CEO Cameron Durrant said in a statement. “We are encouraged by our Type B meeting and remain confident in our program and preparedness plans in advance of a potential EUA.”

READ: Humanigen inks partnership with Thermo Fisher to speed production of coronavirus drug lenzilumab

Humanigen also announced that enrollment in the aforementioned Phase 3 study is continuing in the US and Brazil and has now been approved to expand to Mexico. 

The randomized, placebo-controlled, double-blinded Phase 3 trial currently has a total of 29 approved sites with 24 actively enrolling hospitalized adult COVID-19 patients, who require supplemental oxygen and are at high risk of disease progression.

Lenzilumab is designed to treat what is known as the cytokine storm, an overactive immune response to conditions such as COVID-19 that can cause inflammation, fatigue and, in severe cases, organ failure.

“Lenzilumab is one of the few Phase 3 treatment options in development for COVID-19 and has the potential to be a first-line treatment to improve time to recovery and prevent serious and potentially fatal outcomes in patients who are hospitalized with COVID-19,” Chief Scientific Officer Dale Chappell said. “The addition of new trial sites in Brazil and Mexico expands access to this study, which is especially critical for regions experiencing a surge in cases, including centers, which are already enrolling in the US in areas referred to as ‘hot-spots.’”

There are 17 active trial sites in the US, the company said, including in Los Angeles, Dallas, Orlando, Jacksonville, Charlotte, Atlanta and Minneapolis.

“Trial enrollment continues as we work towards top-line data announcement in the fourth quarter. In parallel, we are furthering our large-scale commercial manufacturing production efforts, having recently announced agreements with Thermo Fisher and Lonza, in addition to Catalent, which are planned to ensure access to lenzilumab if granted EUA.”

Contact Andrew Kessel at [email protected]

Follow him on Twitter @andrew_kessel

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on 07/31/2020

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