TARRYTOWN, N.Y., July 20, 2021 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
that Japan's Ministry of Health,
Labour and Welfare (MHLW) has approved Regeneron's casirivimab and
imdevimab antibody cocktail to treat patients with mild to moderate
COVID-19. This marks the first time the antibody cocktail, known as
REGEN-COVTM in the U.S. and Ronapreve™ in other
countries, has received a full approval to treat COVID-19.
Emergency or temporary pandemic use authorizations are currently in
place in more than 20 countries, including in the U.S., European
Union, India, Switzerland and Canada.
"After a record-speed discovery and development program, we are
pleased that our COVID-19 antibody cocktail continues to reach even
more people around the globe," said George
D. Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer of Regeneron. "Unfortunately, this virus continues to
spread despite increasing rates of vaccination, and there will be
an important continued need for treatments that remain active
against the variants of concern."
In Japan, the antibody cocktail
was granted a Special Approval Pathway under article 14-3 of the
Pharmaceuticals and Medical Devices Act. The approval was based on
results from a Phase 3 trial in high-risk non-hospitalized
patients, which showed the antibody cocktail reduced the risk of
hospitalization or death by 70%, as well as results from a Phase 1
trial that examined the safety, tolerability and pharmacokinetics
in Japanese people.
Regeneron invented REGEN-COV and is collaborating with
Roche to increase global supply of the antibody cocktail, with
Roche primarily responsible for development and distribution
outside the U.S. In December 2020,
Chugai obtained development and exclusive commercialization rights
in Japan from Roche, and is
working with the Japanese government to ensure an appropriate and
timely supply of the antibody cocktail.
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.
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
Science.
Over the past few months Regeneron has announced results from
multiple Phase 3 trials demonstrating the ability of REGEN-COV to
reduce the burden of COVID-19, from prevention through to
hospitalization. This includes trials assessing the ability of
REGEN-COV to treat outpatients already infected with SARS-COV-2
(including symptomatic outpatients and recently infected
asymptomatic patients) and in certain hospitalized patients,
including the RECOVERY trial.
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.; consequently,
REGEN-COV remains available for use in all 50 states. REGEN-COV
retains potency against variants including Delta (B.1.162.2; first
identified in India), Gamma (P.1;
first identified in Brazil), Beta
(B.1.351; first identified in South
Africa).
REGEN-COV is available throughout the U.S. – information on
availability in your area is available from the Department of
Health and Human Services and the National Infusion Center
Association. REGEN-COV has not been approved by the U.S. Food and
Drug Administration (FDA), but is currently authorized in the
U.S. under an Emergency Use Authorization (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.
This use is 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. REGEN-COV is not authorized 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.
In the U.S., REGEN-COV can be administered by intravenous
infusion (as short as 20 minutes) or by subcutaneous injection (4
injections), which is an alternative when intravenous infusion is
not feasible and would lead to a delay in treatment. It is now
authorized as a co-formulated single vial, or in individual vials
to be administered together.
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 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 USE AND IMPORTANT SAFETY
INFORMATION
REGEN-COV, (casirivimab and imdevimab)
co-formulated product and REGEN-COV (casirivimab and imdevimab)
supplied as individual vials to be administered together, 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.
[see Limitations of Authorized Use]
- REGEN-COV has not been approved, but has been authorized for
emergency use by FDA
- This use is 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 use 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
Limitations of Authorized Use
- REGEN-COV (casirivimab and imdevimab) 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
- Benefit of treatment with REGEN-COV has not been observed in
patients hospitalized due to 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
Definition of High Risk Patients
The following
medical conditions or other factors may place adults and pediatric
patients (age 12-17 years and weighing at least 40 kg) at higher
risk for progression to severe COVID-19:
- Older age (for example, age ≥65 years of age)
- Obesity or being overweight (for example, BMI >25
kg/m2, or if age 12-17, have BMI ≥85th percentile for
their age and gender based on CDC growth charts,
https://www.cdc.gov/growthcharts/clinical_charts.htm)
- Pregnancy
- Chronic kidney disease
- Diabetes
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease (including congenital heart disease) or
hypertension
- Chronic lung diseases (for example, chronic obstructive
pulmonary disease, asthma [moderate-to-severe], interstitial lung
disease, cystic fibrosis and pulmonary hypertension)
- Sickle cell disease
- Neurodevelopmental disorders (for example, cerebral palsy) or
other conditions that confer medical complexity (for example,
genetic or metabolic syndromes and severe congenital
anomalies)
- Having a medical-related technological dependence (for example,
tracheostomy, gastrostomy, or positive pressure ventilation (not
related to COVID 19))
Other medical conditions or factors (for example, race or
ethnicity) may also place individual patients at high risk for
progression to severe COVID-19 and authorization of REGEN-COV under
the EUA is not limited to the medical conditions or factors listed
above.
For additional information on medical conditions and factors
associated with increased risk for progression to severe COVID, see
the CDC website:
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html.
Healthcare providers should consider the benefit-risk for an
individual patient.
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
- 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, arrythmia (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, arrythmia (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: Benefit of treatment with REGEN-COV has
not been observed in patients hospitalized due to 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:
-
- In a pooled phase 1/2/3 analysis of COV-2067, 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
- Overall, in Phase 1/2/3, 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
- The safety with subcutaneous administration is based on
analysis from HV-2093, a randomized double-blind,
placebo-controlled trial evaluating the safety and pharmacokinetic
profile in healthy volunteer adult subjects. Subjects were
randomized 3:1 to REGEN-COV (n=729) or placebo (n=240). Injection
site reactions were observed in 12% and 4% of subjects following
single dose administration in the casirivimab and imdevimab, and
placebo arms respectively; the remaining safety findings with
subcutaneous administration in the casirivimab and imdevimab arm
were similar to the safety findings observed with intravenous
administration in COV-2067
- Patient Monitoring Recommendations: Clinically monitor
patients during infusion 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
Regeneron's casirivimab and imdevimab antibody cocktail known as
REGEN-COVTM in the United
States and RonapreveTM in other countries; 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) and new indications for Regeneron's Products;
whether the EUA for REGEN-COV will be expanded for use for
appropriate hospitalized patients and/or in the prevention setting;
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 and Ronapreve in other
countries), 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
Sarah
Cornhill
media@regeneron.com
|
Investor
Relations
Vesna
Tosic
investor@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.