TARRYTOWN, N.Y., Oct. 14, 2021 /PRNewswire/
-- Regeneron Pharmaceuticals, Inc. (NASDAQ:
REGN) today announced that the U.S. Food and Drug
Administration (FDA) has accepted for priority review a Biologics
License Application (BLA) for REGEN-COV® (casirivimab
and imdevimab) to treat COVID-19 in non-hospitalized patients and
as prophylaxis in certain individuals. The FDA has assigned a
target action date of April 13, 2022
and informed us that they currently are planning to hold an
advisory committee meeting to discuss this application in advance
of that date.
The BLA is supported by two positive Phase 3 trials involving
more than 6,000 patients that evaluated the efficacy and safety of
REGEN-COV to treat non-hospitalized patients already infected
with SARS-CoV-2, and to prevent symptomatic infection in
asymptomatic household contacts of SARS-CoV-2 infected individuals
(both uninfected and infected contacts). A second
BLA submission focusing on the treatment of patients hospitalized
due to COVID-19 is expected to be submitted later this year.
Regulatory submissions are also progressing in the European
Union (EU). Earlier this week, the European Medicines Agency
(EMA) accepted for review the Marketing Authorization
Application for the same antibody cocktail, known as Ronapreve™ in
the EU and other countries outside of the U.S., for use in certain
people either as a treatment in infected non-hospitalized patients,
or as prophylaxis. The submission approach for the EMA is similar
to that used for the FDA, with a Type II Variation planned in
those already hospitalized because of COVID-19.
In the U.S., REGEN-COV has not been approved by the FDA, but is
currently authorized under an Emergency Use Authorization (EUA)
to treat people with mild to moderate COVID-19 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. REGEN-COV is available for free to eligible
people as part of a U.S. government funded program, and in
September Regeneron announced a new agreement with the U.S.
government to supply an additional 1.4 million 1,200 mg doses of
REGEN-COV by January 2022.
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.
The development and manufacturing of REGEN-COV have been funded
in part with federal funds from the Biomedical Advanced Research
and Development Authority, part of the U.S. Department of Health
and Human Services' Office of the Assistant Secretary for
Preparedness and Response, under OT number: HHSO100201700020C.
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.
Multiple analyses have shown that the antibody cocktail retains
potency against the main variants of concern, including Delta
(first identified in India), Gamma
(first identified in Brazil), Beta
(first identified in South Africa) and Mu (first identified in
Colombia), with information
available in the Fact Sheet for Healthcare Providers. Regeneron
will continue actively monitoring the potency of REGEN-COV against
emerging variants.
REGEN-COV has not been approved by the FDA, but is currently
authorized for emergency use for the treatment and post-exposure
prophylaxis in certain high risk individuals. 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. This authorization is 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. Additional information about
REGEN-COV in the U.S. is below (authorized uses and important
safety information).
REGEN-COV is an investigational medicine that has emergency or
temporary pandemic authorizations currently in place in more
than 40 countries, including the U.S., several countries in the EU,
India, Switzerland and Canada, and the antibody cocktail is fully
approved in Japan and
conditionally approved in the UK.
Regeneron invented REGEN-COV and is collaborating with
Roche to increase global supply, with Roche primarily responsible
for development and distribution outside the U.S. Regeneron and
Roche share a commitment to making the antibody cocktail available
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 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
- Adverse Reactions:
-
- 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; 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
Applications and Marketing Authorization Applications filed or
planned to be filed with the U.S. Food and Drug Administration (the
"FDA") and the European Medicines Agency, respectively, and
referenced in this press release) and new indications for
Regeneron's Products; the utilization, market acceptance, and
commercial success of Regeneron's Products and Regeneron's Product
Candidates (such as REGEN-COV), including the impact of
recommendations, guidelines, or studies (whether conducted by
Regeneron or others and whether mandated or voluntary), such as the
studies referenced in this press release, on any of the foregoing
or any potential regulatory approval of Regeneron's Products
and Regeneron's Product Candidates; how long the Emergency Use
Authorization ("EUA") granted by 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 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 and Ronapreve™ in other countries) and its
REGEN-COV supply agreement with the U.S. government referenced in
this press release, 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 June 30, 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
|
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SOURCE Regeneron Pharmaceuticals, Inc.