Humanigen Initiates Submission for Lenzilumab Marketing Authorization in COVID-19, to the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA)
Humanigen begins process for UK authorization through a rolling review submission
Application supported by data from the LIVE-AIR phase 3 clinical study
BURLINGAME, CALIF.--(Business Wire / Korea Newswire) June 15, 2021 -- Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’, today 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.”
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of inflammation and immuno-oncology. Humanigen’s immediate focus is to prevent or minimize cytokine release syndrome that precedes severe lung dysfunction in hospitalized and hypoxic patients with COVID-19 pneumonia. Humanigen is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) and cytokine release syndrome associated with CAR-T, bispecific, and other T-cell-engaging therapies, eosinophilic asthma, and rheumatoid arthritis. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.
Humanigen Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements, including, without limitation, statements regarding our request for and receipt of an Emergency Use Authorization from FDA for lenzilumab in COVID-19; our request and receipt of Marketing Authorization or Conditional Marketing Authorization for lenzilumab in Covid-19 by the MHRA; and our other plans relating to lenzilumab as a result of the release of the topline results.
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the “Risk Factors” sections of our latest annual and quarterly reports and other filings with the SEC.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this presentation to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.
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