Humanigen Initiates Submission for Lenzilumab Marketing Authorization in COVID-19, to the United Kingdom’s Medicines & Heal...
June 14 2021 - 6:30AM
Business Wire
- Humanigen begins process for UK authorization through a rolling
review submission
- Application supported by data from the LIVE-AIR phase 3
clinical study
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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version on businesswire.com: https://www.businesswire.com/news/home/20210614005224/en/
Humanigen Media Grace Catlett RXMD gcatlett@rxmedyn.com
516-318-8563
Humanigen Investor Relations Ken Trbovich Humanigen
trbo@humanigen.com 650-410-3206
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