TARRYTOWN, N.Y., Aug. 4, 2021 /PRNewswire/
-- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
today announced that the New England Journal of
Medicine (NEJM) published positive detailed results from
a Phase 3 trial that assessed the ability of REGEN-COV™
(casirivimab and imdevimab) to prevent COVID-19 infection among
household contacts of SARS-CoV-2 infected individuals. The trial
met its primary endpoint, reducing the risk of symptomatic
infections by 81% (p<0.001), with a 93% reduction of
symptomatic infections after the first week, and no
dose-limiting toxicities observed.
"This peer-reviewed NEJM publication demonstrates that
REGEN-COV provides rapid and robust protection to prevent
SARS-CoV-2 infection, and follows data showing that REGEN-COV
maintains effectiveness against all variants of concern," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer at Regeneron. "Despite the
increased uptake of vaccines, SARS-CoV-2 has not been eradicated.
In addition, growing evidence suggests that a substantial number of
individuals, such as the immunocompromised, will not respond
satisfactorily to vaccines. Thus, we believe there is a significant
need for complementary medicines such as REGEN-COV to help prevent
the spread of SARS-CoV-2 infection, particularly in these
immunocompromised patients."
Regeneron previously announced initial results from the
Phase 3 trial, which was jointly run with the COVID-19 Prevention
Trials Network (CoVPN) National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health
(NIH).
The robust REGEN-COV development program has reported positive
Phase 3 trial results across the spectrum of COVID-19 infection,
from prevention to hospitalization:
- Prevention of symptomatic infection in asymptomatic household
contacts of SARS-CoV-2 infected individuals (both uninfected
contacts as detailed in today's publication, and infected
contacts)
- Treatment of non-hospitalized patients already infected with
SARS-CoV-2
- Treatment of certain patients hospitalized due to COVID-19
infection, including the RECOVERY trial
In the U.S., REGEN-COV is currently authorized to treat people
who are at high risk of serious consequences from COVID-19
infection who are either already infected (non-hospitalized) or in
certain post-exposure prophylaxis settings. Post-exposure
prophylaxis with REGEN-COV is not a substitute for vaccination
against COVID-19. REGEN-COV is not authorized for pre-exposure
prophylaxis for prevention of COVID-19 or for use in patients who
are hospitalized due to COVID-19 or require oxygen therapy, or for
people currently using chronic oxygen therapy because of an
underlying comorbidity who require an increase in baseline oxygen
flow rate due to COVID-19. REGEN-COV has not been approved by the
Food and Drug Administration (FDA), but is currently authorized for
the duration of the declaration that circumstances exist justifying
the authorization of the emergency uses under section 564(b)(1) of
the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is
terminated or revoked sooner.
REGEN-COV use is increasing across the U.S. following the latest
surge, with recent weekly orders surpassing 50,000 doses. In
addition to the increasing proportion of patients who now receive
REGEN-COV, Regeneron continues to work to ensure all healthcare
providers and people who may benefit from this important therapy
are aware of its availability.
Multiple analyses, including a recent publication
in Cell, have shown that REGEN-COV retains potency
against the main variants of concern circulating within
the U.S., including Delta (B.1.617.2; first identified
in India), Gamma (P.1; first identified in Brazil) and
Beta (B.1.351; first identified in South Africa).
Consequently, REGEN-COV remains available for use across
the U.S., and Regeneron will continue actively monitoring the
potency of REGEN-COV against emerging variants.
The development and manufacturing of REGEN-COV have been funded
in part with federal funds from the Biomedical Advanced Research
and Development Authority (BARDA), part of the U.S. Department of
Health and Human Services' Office of the Assistant Secretary for
Preparedness and Response, under OT number: HHSO100201700020C.
Regeneron is collaborating with Roche to increase global
supply of the antibody cocktail, with Roche primarily responsible
for development and distribution outside the U.S. Regeneron and
Roche share a commitment to making the antibody cocktail available
to COVID-19 patients around the globe and will support access in
low- and lower-middle-income countries through drug donations to be
made in partnership with public health organizations.
About the Trial
The Phase 3 double-blind,
placebo-controlled trial enrolled people who lived in the same
household as an individual who was diagnosed with SARS-CoV-2 within
the prior 4 days. All participants were tested for SARS-CoV-2 at
baseline using a RT-qPCR test from nasopharyngeal swabs and for the
presence of antibodies using serum antibody testing. Participants
were randomized (1:1) to receive either 1 dose of REGEN-COV (1,200
mg) or placebo, administered via 4 subcutaneous injections.
Among the 1,505 people included in the primary analysis, as they
were not infected with SARS-CoV-2 and did not have antibodies for
SARS-CoV-2 (seronegative) at baseline, 41% identified as
Hispanic/Latino and 9% identified as Black/African American. In
total, approximately 75% of participants had at least one known
factor that put them at high risk of suffering severe consequences
from COVID-19, as defined in the EUA fact sheet. In addition, 34%
were obese and 38% were aged ≥50 years (median age: 34 years;
range: 12-92 years).
About the REGEN-COV Antibody Cocktail
REGEN-COV
(casirivimab and imdevimab) is a cocktail of two monoclonal
antibodies that was designed specifically to block infectivity of
SARS-CoV-2, the virus that causes COVID-19, using Regeneron's
proprietary VelocImmune® and
VelociSuite® technologies. The two potent,
virus-neutralizing antibodies that form the cocktail bind
non-competitively to the critical receptor binding domain of the
virus's spike protein, which diminishes the ability of mutant
viruses to escape treatment and protects against spike variants
that have arisen in the human population, as detailed
in Cell and Science.
REGEN-COV is currently available via emergency or temporary
pandemic use authorizations in more than 20 countries, including in
the U.S., European Union, India,
Switzerland and Canada, and is also fully approved in
Japan.
Information on how to access REGEN-COV throughout the U.S. is
available from the Department of Health and Human Services and the
National Infusion Center Association.
In the U.S., for post-exposure prophylaxis use REGEN-COV 1,200
mg (600 mg casirivimab and 600 mg imdevimab) can be administered by
subcutaneous injection (4 injections), or by intravenous infusion
(as short as 20 minutes). It is available as a co-formulated single
vial, or in individual vials to be administered together. For
people who aren't expected to mount an adequate immune response to
vaccination and who have an ongoing exposure to SARS-CoV-2 for more
than four weeks, the initial 1,200 mg dose can be followed by
subsequent repeat dosing of REGEN-COV 600 mg once every four weeks,
for the duration of ongoing exposure.
In addition to post-exposure prophylaxis, in November 2020 the FDA authorized
REGEN-COV in the U.S. under an EUA to treat mild-to-moderate
COVID-19 in adults and pediatric patients (12 years of age and
older weighing ≥40 kg) with positive results of direct SARS-CoV-2
viral testing, and who are at high risk for progression to severe
COVID-19, including hospitalization or death.
About Regeneron's VelocImmune
Technology
Regeneron's VelocImmune technology
utilizes a proprietary genetically engineered mouse platform
endowed with a genetically humanized immune system to produce
optimized fully human antibodies. When Regeneron's President and
Chief Scientific Officer George D.
Yancopoulos was a graduate student with his mentor
Frederick W. Alt in 1985, they were
the first to envision making such a genetically humanized mouse,
and Regeneron has spent decades inventing and developing
VelocImmune and related VelociSuite technologies. Dr.
Yancopoulos and his team have used VelocImmune technology to
create approximately a quarter of all original, FDA-approved fully
human monoclonal antibodies currently available. This includes
REGEN–COV (casirivimab and imdevimab), Dupixent®
(dupilumab), Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab),
Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab,
maftivimab and odesivimab-ebgn).
AUTHORIZED USES AND IMPORTANT SAFETY INFORMATION
Treatment:
REGEN-COV is authorized for the treatment
of mild to moderate coronavirus disease 2019 (COVID-19) in adults
and pediatric patients (12 years of age and older weighing at least
40 kg) with positive results of direct SARS-CoV-2 viral testing,
and who are at high risk for progression to severe COVID-19,
including hospitalization or death
Limitations of Authorized Use (Treatment)
-- REGEN-COV is not authorized for use in patients:
- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19,
OR
- who require an increase in baseline oxygen
flow rate due to COVID-19 in those on chronic oxygen therapy due to
underlying non-COVID-19 related comorbidity
-- Monoclonal antibodies, such as REGEN-COV, may be associated with
worse clinical outcomes when administered to hospitalized patients
with COVID-19 requiring high-flow oxygen or mechanical
ventilation
Post-Exposure Prophylaxis:
REGEN-COV is authorized in
adult and pediatric individuals (12 years of age and older weighing
at least 40 kg) for post-exposure prophylaxis of COVID-19 in
individuals who are at high risk for progression to severe
COVID-19, including hospitalization or death, and are:
-- not fully vaccinated or who are not expected to mount
an adequate immune response to complete SARS-CoV-2 vaccination (for
example, individuals with immunocompromising conditions including
those taking immunosuppressive medications) and
- have been exposed to an individual infected
with SARS-CoV-2 consistent with close contact criteria per Centers
for Disease Control and Prevention (CDC) or
- who are at high risk of exposure to an
individual infected with SARS-CoV-2 because of occurrence of
SARS-CoV-2 infection in other individuals in the same institutional
setting (for example, nursing homes, prisons)
Limitations of Authorized Use (Post-Exposure
Prophylaxis)
- Post-exposure prophylaxis with REGEN-COV is not a substitute
for vaccination against COVID-19
- REGEN-COV is not authorized for pre-exposure prophylaxis for
prevention of COVID-19
REGEN-COV has not been approved, but has been authorized for
emergency use by FDA
These uses are authorized only for the duration of the
declaration that circumstances exist justifying the authorization
of the emergency use under section 564(b)(1) of the Act,
21 U.S.C. § 360bbb-3(b)(1), unless the authorization is
terminated or revoked sooner
Healthcare providers should review the Fact Sheet for
Healthcare Providers for information on the authorized
uses of REGEN-COV and mandatory requirements of the EUA and must
comply with the requirements of the EUA. The FDA Letter of
Authorization is available for reference, as well
as the Dear Healthcare Provider Letter and Patient
Fact Sheet
Criteria for Identifying High Risk Individuals
Please refer to the Fact Sheet for Healthcare Providers for
criteria for identifying high risk individuals
SARS-CoV-2 Viral Variants
Circulating SARS-CoV-2 viral variants may be associated with
resistance to monoclonal antibodies. Healthcare providers should
review the Antiviral Resistance information in Section 15 of the
Fact Sheet for details regarding specific variants and resistance,
and refer to the CDC website
(https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant-cases.html)
as well as information from state and local health authorities
regarding reports of viral variants of importance in their region
to guide treatment decisions
Important Safety Information
REGEN-COV (casirivimab and imdevimab) is an unapproved
investigational therapy, and there are limited clinical data
available. Serious and unexpected adverse events may occur that
have not been previously reported with REGEN-COV use
- Contraindication:
REGEN-COV is contraindicated in
individuals with previous severe hypersensitivity reactions,
including anaphylaxis, to REGEN-COV
- Warnings and Precautions:
- Hypersensitivity Including Anaphylaxis and Infusion-Related
Reactions: Serious hypersensitivity reactions, including
anaphylaxis, have been observed with administration of REGEN-COV.
If signs or symptoms of a clinically significant hypersensitivity
reaction or anaphylaxis occur, immediately discontinue
administration and initiate appropriate medications and/or
supportive therapy. Hypersensitivity reactions occurring more than
24 hours after the infusion have also been reported with the use of
REGEN-COV under EUA. Infusion-related reactions, occurring during
the infusion and up to 24 hours after the infusion, have been
observed with administration of REGEN-COV. These reactions may be
severe or life threatening
-- Signs and symptoms of infusion-related reactions may
include: fever, difficulty breathing, reduced oxygen
saturation, chills, nausea, arrhythmia (e.g., atrial fibrillation,
tachycardia, bradycardia), chest pain or discomfort, weakness,
altered mental status, headache, bronchospasm, hypotension,
hypertension, angioedema, throat irritation, rash including
urticaria, pruritus, myalgia, vasovagal reactions (e.g.,
pre-syncope, syncope), dizziness, fatigue and diaphoresis. Consider
slowing or stopping the infusion and administer appropriate
medications and/or supportive care if an infusion-related reaction
occurs
- Clinical Worsening After REGEN-COV
Administration: Clinical worsening of COVID-19 after
administration of REGEN-COV has been reported and may include signs
or symptoms of fever, hypoxia or increased respiratory difficulty,
arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia),
fatigue, and altered mental status. Some of these events required
hospitalization. It is not known if these events were related to
REGEN-COV use or were due to progression of COVID-19
-
Limitations of Benefit and Potential for Risk in Patients with
Severe COVID-19: Monoclonal antibodies, such as REGEN-COV,
may be associated with worse clinical outcomes when administered to
hospitalized patients with COVID-19 requiring high-flow oxygen or
mechanical ventilation. Therefore, REGEN-COV is not authorized for
use in patients who are hospitalized due to COVID-19, OR who
require oxygen therapy due to COVID-19, OR who require an increase
in baseline oxygen flow rate due to COVID-19 in those on chronic
oxygen therapy due to underlying non-COVID-19–related
comorbidity
- COV-2067 (Treatment): Infusion-related reactions (adverse
event assessed as causally related by the investigator) of grade 2
or higher severity have been observed in 10/4,206 (0.2%) of those
who received REGEN-COV at the authorized dose or a higher dose.
Three subjects receiving the 8,000 mg dose of REGEN-COV, and one
subject receiving the 1,200 mg casirivimab and 1,200 mg imdevimab,
had infusion-related reactions (urticaria, pruritus, flushing,
pyrexia, shortness of breath, chest tightness, nausea, vomiting,
rash) which resulted in permanent discontinuation of the infusion.
All events resolved. Anaphylactic reactions have been reported in
the clinical program in subjects receiving REGEN-COV. The events
began within 1 hour of completion of the infusion, and in at least
one case required treatment including epinephrine. The events
resolved
- COV-2069 (Post-exposure prophylaxis): In subjects who
were SARS-CoV-2 negative at baseline (Cohort A), injection site
reactions (all grade 1 and 2) occurred in 55 subjects (4%) in the
REGEN-COV group and 19 subjects (2%) in the placebo group. The most
common signs and symptoms of injection site reactions which
occurred in at least 1% of subjects in the REGEN-COV group were
erythema and pruritus. Hypersensitivity reactions occurred in
2 subjects (0.2%) in the REGEN-COV group and all hypersensitivity
reactions were grade 1 in severity. In subjects who were SARS-CoV-2
positive at baseline (Cohort B), injection site reactions, all of
which were grade 1 or 2, occurred in 6 subjects (4%) in the
REGEN-COV group and 1 subject (1%) in the placebo group. The most
common signs and symptoms of injection site reactions which
occurred in at least 1% of subjects in the REGEN-COV group were
ecchymosis and erythema
-
COV-2093 (Subcutaneous Dosing): Injection site
reactions occurred in 12% and 4% of subjects following single dose
administration in the REGEN-COV and placebo groups, respectively.
Remaining safety finding following subcutaneous administration in
the REGEN-COV group were similar to the safety findings observed
with intravenous administration in COV-2067. With repeat dosing,
injection site reactions occurred in 252 subjects (35%) in the
REGEN-COV group and 38 subjects (16%) in the placebo group; all
injection site reactions were grade 1 or 2 in severity.
Hypersensitivity reactions occurred in 8 subjects (1%) in the
REGEN-COV group; and all hypersensitivity reactions were grade 1 or
2 in severity. There were no cases of anaphylaxis
- Patient Monitoring Recommendations: Clinically monitor
patients during dose administration and observe patients for at
least 1 hour after intravenous infusion or subcutaneous dosing is
complete
- Use in Specific Populations:
- Pregnancy: There are insufficient data to evaluate a
drug-associated risk of major birth defects, miscarriage, or
adverse maternal or fetal outcomes. REGEN-COV should only be used
during pregnancy if the potential benefit outweighs the potential
risk for the mother and the fetus
-
Lactation: There are no available data on the presence
of casirivimab and/or imdevimab in human milk or animal milk, the
effects on the breastfed infant, or the effects of the drug on milk
production. The development and health benefits of breastfeeding
should be considered along with the mother's clinical need for
REGEN-COV and any potential adverse effects on the breastfed child
from REGEN-COV or from the underlying maternal condition
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 nine
FDA-approved treatments and numerous product candidates in
development, almost 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, hematologic
conditions, 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 or otherwise commercialized 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 product candidates being developed by Regeneron and/or
its collaborators (collectively, "Regeneron's Product Candidates")
and research and clinical programs now underway or planned,
including without limitation the development program relating to
the REGEN-COV™ (casirivimab and imdevimab)
antibody cocktail; how long the Emergency Use Authorization ("EUA")
granted by the U.S. Food and Drug Administration (the
"FDA") for REGEN-COV will remain in effect and whether the EUA is
revoked by the FDA based on its determination that the underlying
health emergency no longer exists or warrants such authorization or
other reasons; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron's Product
Candidates (such as REGEN-COV, including based on the Biologics
License Application planned to be filed with the FDA and referenced
in this press release) and new indications for Regeneron's
Products; whether, based on the data discussed in this press
release or otherwise, the EUA for REGEN-COV will be expanded to
include COVID-19 prevention for appropriate populations;
uncertainty of the utilization, market acceptance, and commercial
success of Regeneron's Products and Regeneron's Product Candidates,
including the impact of recommendations, guidelines, or
studies (whether conducted by Regeneron or others and whether
mandated or voluntary) on any of the foregoing or any potential
regulatory approval of Regeneron's Products and Regeneron's
Product Candidates (such as REGEN-COV); 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 Regeneron's Product Candidates (including
REGEN-COV) and the impact of the foregoing on Regeneron's ability
to supply Regeneron's Products and Regeneron's Product Candidates
(including REGEN-COV); the ability of Regeneron to manage supply
chains for multiple products and product candidates; safety issues
resulting from the administration of Regeneron's Products and
Regeneron's Product Candidates (such as REGEN-COV) in patients,
including serious complications or side effects in connection with
the use of Regeneron's Products and Regeneron's Product Candidates
in clinical trials; 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 Regeneron's Product Candidates, including without
limitation REGEN-COV; 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 Regeneron's
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; 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, collaboration, or supply
agreement, including Regeneron's agreements with Sanofi, Bayer, and
Teva Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), as well as Regeneron's collaboration
with Roche relating to the casirivimab and imdevimab antibody
cocktail (known as REGEN-COV in the United States), 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),
Praluent® (alirocumab), and REGEN-COV), 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, 2020 and its Form 10-Q for the
quarterly period ended March 31, 2021. 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
Tammy
Allen
media@regeneron.com
|
Investor
Relations
Vesna
Tosic
investor@regeneron.com
|
View original
content:https://www.prnewswire.com/news-releases/new-england-journal-of-medicine-publishes-positive-phase-3-trial-results-for-regen-cov-casirivimab-and-imdevimab-to-prevent-sars-cov-2-infection-301348764.html
SOURCE Regeneron Pharmaceuticals, Inc.