UK’s MHRA accepts Humanigen’s submission of Lenzilumab for Marketing Authorization in COVID-19 for expedited rolling review
July 09 2021 - 6:30AM
Business Wire
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), today announced
its submission for Marketing Authorization for lenzilumab in
COVID-19, begun in June 2021, has been accepted by the United
Kingdom’s (UK’s) Medicines and Healthcare Products Regulatory
Agency (MHRA) for expedited COVID-related rolling review, with
assessment expected to occur more rapidly than a standard rolling
review.
Leading up to initiating its submission for Marketing
Authorization last month, Humanigen held meetings with various
authorities in the UK, including a Rapid C-19 multiagency meeting
with representatives from the MHRA, the Therapeutics TaskForce,
(TTF), the Department of Health and Social Care (DHSC), National
Health Service England (NHSE) and the National Institute for Heath
and Care Excellence (NICE).
“We are grateful this submission will receive expedited
consideration by MHRA,” said Cameron Durrant, CEO of Humanigen.
“The global spread of variants of concern, such as the Delta
variant, highlights the continued need for proven therapies that
are variant-agnostic for millions who remain at risk of
COVID-19.”
According to Public Health England, despite the first dose
vaccination rate of 86% across the UK, the current seven-day
hospitalization rate was nearly 2,500, representing a 45% increase
over the prior period. Deaths from COVID in the UK reached 161 over
the last seven days, an increase of more than 40% compared to the
prior seven-day period.1
“We continue to work with our partners to prepare for
distribution of lenzilumab pending conditional approval of its use
to treat hospitalized patients with COVID-19,” noted Timothy E.
Morris, COO and CFO of Humanigen. “In the event Emergency Use
Authorization in the United States and Marketing Authorization in
the UK are awarded concurrently or in parallel, we will work with
the relevant authorities to ensure appropriate allocation of
lenzilumab in each country.”
About Humanigen, Inc.
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
of 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 is developing lenzilumab as a
treatment for cytokine storm associated with CD19-targeted CAR-T
cell therapies and 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), eosinophilic asthma, and rheumatoid
arthritis. Humanigen is also developing a portfolio of clinical and
pre-clinical therapies for the treatment of inflammation and
immuno-oncology. 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 the review of our submission for
Marketing Authorization for lenzilumab in COVID-19 by the MHRA; our
intentions to manage distribution of lenzilumab upon potential
receipt of Emergency Use Authorization in the US and Marketing
Authorization in the UK; and our other plans to explore the
effectiveness of lenzilumab and other candidates in our development
portfolio as therapies for other inflammation and immune-oncology
indications.
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.
- https://coronavirus.data.gov.uk/ accessed July 7, 2020
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version on businesswire.com: https://www.businesswire.com/news/home/20210709005032/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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