TARRYTOWN, N.Y., Oct. 14, 2020 /PRNewswire/ --
In a large clinical trial, Inmazeb showed superiority
compared to other investigational agents (ZMapp and remdesivir)
with respect to mortality; treatment was most effective when given
early in the course of disease1
Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) is a
novel anti-viral antibody medicine developed using the same 'rapid
response' technologies as Regeneron's investigational COVID-19
antibody combination
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today
that the U.S. Food and Drug Administration (FDA) approved
Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn)
for the treatment of infection caused by Zaire ebolavirus in adult and pediatric
patients, including newborns of mothers who have tested positive
for the infection.
"We are incredibly proud that the FDA has approved Inmazeb,
which is also known as REGN-EB3. This is the first time the FDA has
approved a treatment specifically for Ebola, which has caused a
number of deadly outbreaks," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer of Regeneron. "Decades of investment in our
VelociSuite® rapid response technologies, the
dedication of world-class scientists, and the courageous
contributions of healthcare providers and patients, together with
remarkable cooperation between leading international health
organizations and governments, have led to this important moment.
As we apply the same sophisticated technologies and manufacturing
capabilities against COVID-19, we hope this will be one of many
demonstrations of how the power of science can be successfully
deployed against dangerous infectious diseases."
As part of an agreement announced in July
2020, Regeneron will deliver an established number of
Inmazeb treatment doses over the course of six years to the
Biomedical Advanced Research and Development Authority (BARDA), as
part of the U.S. Department of Health and Human Services' (HHS)
goal of building national preparedness for public health
emergencies.
In keeping with our mission and values, Regeneron is committed
to making this important medicine available to the people who need
it. In response to the 2018 Ebola outbreak in the Democratic Republic of the Congo (DRC), we
worked with the World Health Organization (WHO), U.S. FDA and other
global organizations to offer Inmazeb under a compassionate use
protocol and include it in the four-arm PALM (PAmoja TuLinde
Maisha) Trial. With BARDA support, we continue to provide Inmazeb
for free in response to outbreaks in the DRC through the MEURI
protocol for compassionate use. Regeneron is actively working with
non-governmental organizations and public health agencies to ensure
continued access to Inmazeb in low- and middle-income
countries.
"Since 2015, BARDA has partnered with Regeneron to develop a
life-saving treatment for Ebola Zaire. The Food and Drug
Administration's approval of Inmazeb shows the power of public
private partnerships to bring forward these critical treatments and
improve global public health," said Gary
Disbrow, the Acting Director of BARDA. "BARDA is
continuing our collaboration with Regeneron on other
life-threatening diseases such as MERS and COVID-19, and we look
forward to continued success."
The safety and efficacy of Inmazeb was established through the
681-patient PALM Trial, a randomized, multicenter, controlled trial
initiated in 2018 in the DRC. The WHO, the National Institutes of
Health (NIH) and the Institut National de Recherche Biomédicale
(INRB) in the DRC jointly sponsored and served as co-principal
investigators of the trial. In 2019, as reported in the New
England Journal of Medicine, the PALM Trial was stopped early
following a pre-specified interim analysis that showed superiority
of Inmazeb to ZMapp and remdesivir with respect to
mortality. Adverse events that occurred in at least 10% of
Inmazeb patients were chills, elevation in fever (pyrexia), rapid
heartbeat (tachycardia), rapid breathing (tachypnea), vomiting, low
blood pressure (hypotension), diarrhea and inadequate oxygen supply
to the tissue (hypoxia); of these, only chills occurred more
frequently with Inmazeb than ZMapp. The evaluation of AEs in
Inmazeb patients may have been confounded by the signs and symptoms
of the underlying Zaire
ebolavirus infection.
About Inmazeb
Inmazeb, previously called REGN-EB3, was
created using Regeneron's VelocImmune® platform
and associated VelociSuite® technologies. The
treatment consists of three monoclonal antibodies of similar
structure, atoltivimab, maftivimab and odesivimab, that bind to
different, non-overlapping epitopes on Zaire ebolavirus glycoprotein. The three
antibodies help neutralize the Ebola virus by blocking its ability
to invade patients' and/or enlisting other immune cells to target
infected cells and remove them from the body.
Inmazeb is administered as a single, weight-based intravenous
infusion (50 mg atoltivimab, 50 mg maftivimab and 50 mg odesivimab
per kg). Inmazeb was developed in collaboration and with
federal funds from BARDA, part of the Office of the Assistant
Secretary for Preparedness and Response at the HHS under ongoing
USG Contract Nos. HHSO100201700016C and
HHSO100201500013C.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
INMAZEB is indicated for the treatment of
infection caused by Zaire
ebolavirus in adult and pediatric patients, including neonates
born to a mother who is RT-PCR positive for Zaire ebolavirus infection.
Limitations of Use: The efficacy of INMAZEB has not been
established for other species of the Ebolavirus and
Marburgvirus genera. Zaire ebolavirus can change over time, and
factors such as emergence of resistance, or changes in viral
virulence could diminish the clinical benefit of antiviral drugs.
Consider available information on drug susceptibility patterns for
circulating Zaire
ebolavirus strains when deciding to use INMAZEB.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions Including Infusion-Associated
Events: Hypersensitivity reactions including
infusion-associated events have been reported during and
post-infusion with INMAZEB. These may include acute,
life-threatening reactions during and after the infusion. Monitor
all patients for signs and symptoms including, but not limited to,
hypotension, chills and elevation of fever, during and following
INMAZEB infusion. In the case of severe or life-threatening
hypersensitivity reactions, discontinue the administration of
INMAZEB immediately and administer appropriate emergency care.
Infusion could not be completed in 1% of subjects who received
INMAZEB due to infusion-associated adverse events. The rate of
infusion of INMAZEB may be slowed or interrupted if the patient
develops any signs of infusion-associated events or other adverse
events.
ADVERSE REACTIONS:
- The most common adverse events reported in at least 10% of
subjects who received INMAZEB were pyrexia (or elevation in fever),
chills, tachycardia, tachypnea, vomiting, hypotension, diarrhea and
hypoxia. The evaluation of adverse events in subjects who received
INMAZEB may have been confounded by the signs and symptoms of the
underlying Zaire ebolavirus
infection.
- Selected grade 3 and 4 laboratory abnormalities for INMAZEB
included high sodium (≥ 154 mmol/L), low sodium (<125 mmol/L),
high potassium (≥ 6.5 mmol/L), low potassium (< 2.5 mmol/L),
creatinine ((mg/dL) ≥ 1.8 x ULN), high alanine aminotransferase
((U/L) ≥ 5 x ULN) and high aspartate aminotransferase ((U/L) ≥ 5 x
ULN).
DRUG INTERACTIONS: INMAZEB may reduce the efficacy
of live vaccine therefore, avoid the concurrent administration of a
live vaccine during treatment with INMAZEB. The interval between
live vaccination following initiation of INMAZEB therapy should be
in accordance with current vaccination guidelines.
Please see accompanying full Prescribing
Information
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to eight
FDA-approved treatments and numerous product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, pain, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune®, which uses unique
genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Forward-Looking Statements and Use of Digital
Media
This press release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. ("Regeneron" or the "Company"), and actual events or results
may differ materially from these forward-looking statements. Words
such as "anticipate," "expect," "intend," "plan," "believe,"
"seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these risks
and uncertainties include, among others, the impact of SARS-CoV-2
(the virus that has caused the COVID-19 pandemic) on Regeneron's
business and its employees, collaborators, and suppliers and other
third parties on which Regeneron relies, Regeneron's and its
collaborators' ability to continue to conduct research and clinical
programs, Regeneron's ability to manage its supply chain, net
product sales of products marketed by Regeneron and/or its
collaborators (collectively, "Regeneron's Products"), and the
global economy; the nature, timing, and possible success and
therapeutic applications of Regeneron's Products and Regeneron's
product candidates and research and clinical programs now underway
or planned, including without limitation Inmazeb®
(atoltivimab, maftivimab and odesivimab-ebgn); uncertainty of
market acceptance and commercial success of Regeneron's Products
and product candidates and the impact of studies (whether conducted
by Regeneron or others and whether mandated or voluntary) on the
commercial success of Regeneron's Products (such as Inmazeb) and
product candidates; safety issues resulting from the administration
of Regeneron's Products (such as Inmazeb) and product candidates in
patients, including serious complications or side effects in
connection with the use of Regeneron's Products and product
candidates in clinical trials; whether Regeneron will be able to
deliver the anticipated number of treatment doses under its
agreement with the Biomedical Advanced Research and Development
Authority, part of the Office of the Assistant Secretary for
Preparedness and Response within the U.S. Department of Health and
Human Services (HHS), discussed in this press release (the "BARDA
Supply Agreement") and the impact of the BARDA Supply Agreement on
Regeneron's financial condition and results of operations; the
likelihood, timing, and scope of possible regulatory approval and
commercial launch of Regeneron's product candidates (including
without limitation REGN-COV2 (Regeneron's investigational
two-antibody cocktail for the treatment and prevention of
COVID-19)) and new indications for Regeneron's Products;
determinations by regulatory and administrative governmental
authorities which may delay or restrict Regeneron's ability to
continue to develop or commercialize Regeneron's Products and
product candidates; ongoing regulatory obligations and oversight
impacting Regeneron's Products, research and clinical programs, and
business, including those relating to patient privacy; the
availability and extent of reimbursement of Regeneron's Products
from third-party payers, including private payer healthcare and
insurance programs, health maintenance organizations, pharmacy
benefit management companies, and government programs such as
Medicare and Medicaid; coverage and reimbursement determinations by
such payers and new policies and procedures adopted by such payers;
competing drugs and product candidates that may be superior to, or
more cost effective than, Regeneron's Products and product
candidates; the extent to which the results from the research and
development programs conducted by Regeneron and/or its
collaborators may be replicated in other studies and/or lead
to advancement of product candidates to clinical trials,
therapeutic applications, or regulatory approval; the ability of
Regeneron to manufacture and manage supply chains for multiple
products and product candidates; the ability of Regeneron's
collaborators, suppliers, or other third parties (as applicable) to
perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's Products and
product candidates; unanticipated expenses; the costs of
developing, producing, and selling products; the ability of
Regeneron to meet any of its financial projections or guidance and
changes to the assumptions underlying those projections or
guidance; the potential for any license or collaboration agreement,
including Regeneron's agreements with Sanofi, Bayer, and Teva
Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), as well as the BARDA Supply Agreement,
to be cancelled or terminated; and risks associated with
intellectual property of other parties and pending or future
litigation relating thereto (including without limitation the
patent litigation and other related proceedings relating to
EYLEA® (aflibercept) Injection, Dupixent®
(dupilumab), and Praluent® (alirocumab)), other
litigation and other proceedings and government investigations
relating to the Company and/or its operations, the ultimate outcome
of any such proceedings and investigations, and the impact any of
the foregoing may have on Regeneron's business, prospects,
operating results, and financial condition. A more complete
description of these and other material risks can be found in
Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the
quarterly period ended June 30, 2020.
Any forward-looking statements are made based on management's
current beliefs and judgment, and the reader is cautioned not to
rely on any forward-looking statements made by Regeneron. Regeneron
does not undertake any obligation to update (publicly or otherwise)
any forward-looking statement, including without limitation any
financial projection or guidance, whether as a result of new
information, future events, or otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (http://newsroom.regeneron.com) and its
Twitter feed (http://twitter.com/regeneron).
Contacts:
Media Relations
Ella
Campbell
Tel: +1 (914) 847-7017
ella.campbell@regeneron.com
Investor Relations
Mark
Hudson
Tel: +1 (914) 847-3482
mark.hudson@regeneron.com
1Mulangu, S, Dodd, LE, Davey, RT, et al.
A Randomized, Controlled Trial of Ebola Virus Disease
Therapeutics. New England Journal of Medicine. 2019;
381(24):2293-2303. doi:10.1056/nejmoa1910993
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SOURCE Regeneron Pharmaceuticals, Inc.
