TARRYTOWN, N.Y., April 9, 2021 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that
newly updated National Institutes of Health (NIH) COVID-19
Treatment Guidelines strongly recommend that REGEN-COV™
(casirivimab with imdevimab) be used in non-hospitalized COVID-19
patients ("outpatients") at high risk of clinical progression.
The Category 'AIIa' is a 'strong' rating based on results of
randomized trials.
The recommendation from the NIH COVID-19 Treatments Guidelines
Panel is a critical step in helping make monoclonal antibody
therapies like REGEN-COV available for all appropriate
patients in the U.S. The new guidelines are based in part on
robust clinical data involving more than 4,500
outpatients showing that REGEN-COV significantly reduced the
risk of hospitalization or death by 70% compared to placebo.
"With these clear new NIH guidelines, Emergency Use
Authorization from the U.S. Food and Drug
Administration, ample supply of REGEN-COV, and the
medicine being supplied free of charge by the U.S. government, the
time for equivocation has passed — we must now all do whatever it
takes to make sure appropriate patients are treated as early as
possible after diagnosis," said Leonard S. Schleifer, M.D., Ph.D., President and
CEO at Regeneron. "If we work together, we can avoid tens of
thousands of needless hospitalizations or deaths from COVID-19. We
will also continue to partner with stakeholders to address other
key bottlenecks such as education, ease of administration and
better systems to ensure infusion reimbursement."
Despite the strong progress being made with vaccination, in the
U.S. approximately 2 million people a month are still diagnosed
with COVID-19 and tens of thousands are at risk of dying from
COVID-19.
Importantly, some NIH panel members recommended
REGEN-COV as the preferred antibody cocktail for COVID-19 in areas
where variants are common, given REGEN-COV's continued potency
in vitro against the variants first identified in the
United Kingdom, Brazil, South
Africa, New York and
California, while acknowledging
that it is not known whether in vitro susceptibility data
correlates with clinical outcomes. The U.S. Food and Drug
Administration (FDA) recently authorized updated Emergency Use
Authorization (EUA) fact sheets for all authorized monoclonal
antibody treatments, which indicate that REGEN-COV is the only
therapy to retain potency against these key emerging variants. In
many parts of the U.S., variants now make up the majority of all
new COVID-19 cases.
"Regeneron continues to innovate to respond to this devastating
pandemic. With approximately 60,000 new infections daily, many of
them in high-risk individuals, it's clear there is an urgent need
to improve access to treatments like REGEN-COV that are proven to
reduce hospitalization or death," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer at Regeneron. "In addition to working
to advance simpler subcutaneous administration of REGEN-COV, we
look forward to sharing additional data soon on the use of
REGEN-COV to prevent infection."
Although REGEN-COV is not currently recommended for people
hospitalized due to COVID-19, the panel recommended that REGEN-COV
use should be considered for persons with mild-to-moderate
COVID-19 who are hospitalized for a reason other than COVID-19
but who otherwise meet the EUA criteria.
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 with imdevimab) is a cocktail of two monoclonal
antibodies (also known as REGN10933 and REGN10987) 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.
Under an EUA issued by the FDA, REGEN-COV is currently
available in the U.S. to treat mild-to-moderate COVID-19 in adults,
as well as in pediatric patients at least 12 years of age and
weighing at least 40 kg, who have received positive results of
direct SARS-CoV-2 viral testing and are at high risk for
progressing to severe COVID-19 and/or hospitalization. REGEN-COV
has not been approved by FDA but has been authorized for emergency
use. 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 currently authorized and available in a 2,400 mg IV
dose, with infusion times as short as 20 minutes. The criteria for
'high-risk' patients are described in the Fact Sheet for
Healthcare Providers. In the U.S., 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.
Under this EUA, 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.
Regeneron is collaborating with Roche to increase global
supply of REGEN-COV. Regeneron is responsible for development and
distribution of the treatment in the U.S., and Roche is primarily
responsible for development and distribution outside the U.S. The
companies 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 co-Founder, 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-COVTM (casirivimab with 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
Authorized Emergency Use
REGEN-COV, (casirivimab with
imdevimab 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 progressing to severe
COVID-19 and/or hospitalization. [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 with 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
High-risk is defined
as patients who meet at least one of the following criteria:
- Have a body mass index (BMI) ≥35
- Have chronic kidney disease
- Have diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Are ≥65 years of age
- Are ≥55 years of age AND have
- cardiovascular disease, OR
- hypertension, OR
- chronic obstructive pulmonary disease/other chronic
respiratory disease.
- Are 12 – 17 years of age AND have
- BMI ≥85th percentile for their age and gender based
on CDC growth charts,
https://www.cdc.gov/growthcharts/clinical_charts.htm,OR
- sickle cell disease, OR
- congenital or acquired heart disease, OR
- neurodevelopmental disorders (e.g., cerebral palsy),
OR
- a medical-related technological dependence, for
example, tracheostomy, gastrostomy,
or positive pressure ventilation
(not related to COVID-19), OR
- asthma, reactive airway or other chronic respiratory
disease that requires daily
medication for control.
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
with 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: There is a potential for serious
hypersensitivity reaction, including anaphylaxis, 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. Infusion-related reactions
have been observed with administration of REGEN-COV.
-
- 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, dizziness, fatigue and diaphoresis.
If an infusion-related reaction occurs, consider slowing or
stopping the infusion and administer appropriate medications and/or
supportive care.
- 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:
- Serious adverse events (SAEs) were reported in 4 (1.6%)
patients in REGEN-COV 2,400 mg group, 2 (0.8%) patients in
REGEN-COV 8,000 mg group and 6 (2.3%) patients in the placebo
group. None of the SAEs were considered to be related to study
drug. SAEs that were reported as Grade 3 or 4 adverse events were
pneumonia, hyperglycemia, nausea and vomiting (2,400 mg REGEN-COV),
intestinal obstruction and dyspnea (8,000 mg REGEN-COV) and
COVID-19, pneumonia and hypoxia (placebo). REGEN-COV is
not authorized at the 8,000 mg dose (4,000 mg casirivimab and
4,000 mg imdevimab).
- One anaphylactic reaction was reported in the clinical program.
The event began within 1 hour of completion of the infusion, and
required treatment including epinephrine. The event resolved.
Infusion-related reactions, of Grade 2 or higher severity, were
reported in 4 subjects (1.5%) in the 8,000 mg (4,000 mg casirivimab
and 4,000 mg imdevimab) arm. These infusion-related reactions
events were moderate in severity; and include pyrexia, chills,
urticaria, pruritus, abdominal pain, and flushing. One
infusion-related reaction (nausea) was reported in the placebo arm
and none were reported in the 2,400 mg (1,200 mg casirivimab and
1,200 mg imdevimab) arm. In two subjects receiving the 8,000 mg
dose of REGEN-COV, the infusion-related reactions (urticaria,
pruritus, flushing, pyrexia, shortness of breath, chest tightness,
nausea, vomiting) resulted in permanent discontinuation of the
infusion. All events resolved.
Patient Monitoring Recommendations: Clinically monitor
patients during infusion and observe patients for at least 1 hour
after infusion is complete.
Use in Specific Populations:
- Pregnancy: There is currently limited clinical
experience in the use of REGEN-COV in COVID-19 patients who are
pregnant. REGEN-COV therapy should be used during pregnancy only if
the potential benefit justifies the potential risk for the mother
and the fetus.
- Lactation: There is currently no clinical
experience in use of REGEN-COV in COVID-19 patients who are
breastfeeding. 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, hematology,
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.
Regeneron Forward-Looking Statements and Use of Digital
Media
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 and research and clinical programs now underway or
planned, including the development program relating to
REGEN-COVTM (casirivimab with 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 (including
REGEN-COV) and new indications for Regeneron's Products; whether
subcutaneous administration of REGEN-COV will be included in the
EUA for REGEN-COV based on previously reported data or otherwise;
uncertainty of the utilization rate, market acceptance, or
commercial success of Regeneron's Products and product candidates
(including REGEN-COV); the impact of recommendations, guidelines
(including the National Institutes of Health COVID-19 Treatment
Guidelines discussed in this press release), or studies (whether
conducted by Regeneron or others and whether mandated or voluntary)
on any potential regulatory approval and/or the utilization rate,
market acceptance, or commercial success of Regeneron's Products
and 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 product candidates (including REGEN-COV)
and the impact of the foregoing on Regeneron's ability to supply
its Products and 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 product candidates (such
as REGEN-COV) in patients, including serious complications or side
effects in connection with the use of Regeneron's Products and
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 product candidates,
including 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 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 REGEN-COV, to be cancelled or terminated;
and risks associated with intellectual property of other parties
and pending or future litigation relating thereto (including 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. 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 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).
Regeneron
Contacts:
Media
Relations
Sarah
Cornhill
media@regeneron.com
|
Investor
Relations
Vesna
Tosic
investor@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.