FDA has declined Humanigen’s Emergency Use Authorization (EUA) Request for Lenzilumab in Hospitalized COVID-19 Patients
September 09 2021 - 12:16AM
Business Wire
- FDA has committed to working with Humanigen in the development
of lenzilumab and has invited Humanigen to submit additional data
as it becomes available
- NIH’s ACTIV-5/BET-B study is expected to provide further data
that may support a new EUA request
- Humanigen remains committed to completing regulatory processes
underway seeking Marketing Authorization for lenzilumab to treat
hospitalized COVID-19 patients in the U.K. and other
territories
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage
biopharmaceutical company focused on preventing and treating an
immune hyper-response called ‘cytokine storm,’ announced today the
U.S. FDA has declined its request for emergency use authorization
of lenzilumab to treat newly hospitalized COVID-19 patients. In its
letter, FDA stated that it was unable to conclude that the known
and potential benefits of lenzilumab outweigh the known and
potential risks of its use as a treatment for COVID-19.
“We remain committed to bringing lenzilumab to patients
hospitalized with COVID-19,” said Cameron Durrant, MD, Chief
Executive Officer, Humanigen. “We believe the ongoing ACTIV-5/BET-B
trial, which has been advanced to enroll up to 500 patients, may
provide additional safety and efficacy data sufficient to support
our efforts to obtain an EUA to treat hospitalized COVID-19
patients.”
About Humanigen
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage
biopharmaceutical company focused on preventing and treating an
immune hyper-response called ‘cytokine storm’. Lenzilumab is a
first-in class antibody that binds to and neutralizes
granulocyte-macrophage colony-stimulating factor (GM-CSF). Results
from preclinical models indicate GM-CSF is an upstream regulator of
many inflammatory cytokines and chemokines involved in the cytokine
storm. Early in the COVID-19 pandemic, investigation showed high
levels of GM-CSF secreting T cells were associated with disease
severity and intensive care unit admission. Humanigen’s Phase 3
LIVE-AIR study suggests early intervention with lenzilumab may
prevent consequences of a full-blown cytokine storm in hospitalized
patients with COVID-19. Humanigen has submitted lenzilumab to
Medicines and Health Regulatory Agency in the United Kingdom for a
rolling review towards potential Marketing Authorization. Humanigen
is developing lenzilumab as a treatment for cytokine storm
associated with COVID-19, CD19-targeted CAR-T cell therapies and
exploring the effectiveness of lenzilumab in other inflammatory
conditions such as acute Graft versus Host Disease in patients
undergoing allogeneic hematopoietic stem cell transplantation,
eosinophilic asthma, and rheumatoid arthritis. For more
information, visit www.humanigen.com and follow Humanigen on
LinkedIn, Twitter, and Facebook.
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 the sufficiency of the data from
the ACTIV-5/BET-B study to warrant a future submission of a new EUA
request; statements regarding our efforts to request and receive
Marketing Authorization or Conditional Marketing Authorization for
lenzilumab in COVID-19 in the U.K. and other territories; and our
other plans relating to lenzilumab.
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uncertainties including, but not limited to, the risks inherent in
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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
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actual results could differ materially from those anticipated in
the forward-looking statements, in each case, except as required by
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version on businesswire.com: https://www.businesswire.com/news/home/20210908006189/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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