TARRYTOWN, N.Y., Feb. 25, 2021 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) today announced changes
to the Phase 3 trial assessing investigational REGEN-COV™
(casirivimab with imdevimab) in non-hospitalized patients
("outpatients") with COVID-19, following recommendations from the
Independent Data Monitoring Committee (IDMC). The IDMC found clear
clinical efficacy on reducing the rate of hospitalization and death
with both the 1,200 mg and 2,400 mg doses of REGEN-COV compared to
placebo, and recommended stopping enrollment into the placebo
group.
Regeneron is following the IDMC recommendation and will
immediately stop enrolling patients in the placebo group. The trial
will continue to enroll patients into both the 1,200 mg and 2,400
mg REGEN-COV treatment groups. The company has not yet had access
to any of the unblinded data, including the relative treatment
benefit of the 1,200 mg and 2,400 mg doses, and will share detailed
results when available in March
2021.
"We appreciate the time and guidance of the IDMC and are
extremely grateful to the thousands of patients and investigators
who have participated in this more than 8,000-patient clinical
trial," said David Weinreich, M.D.,
Executive Vice President and Head of Global Clinical Development at
Regeneron. "REGEN-COV is now available in the U.S. to indicated
high-risk non-hospitalized patients under an Emergency Use
Authorization, and we hope to submit these results as part of
a full Biologics License Application."
"In addition to the clear-cut efficacy that the IDMC has
observed in this trial, it's reassuring that preclinical data
from our labs and independent researchers show that REGEN-COV
effectively neutralizes emerging strains of the virus, which are
becoming increasingly common," said George
D. Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer at Regeneron. "Our cocktail approach using two
functionally-independent antibodies safeguards against variants
that may impact potency to a single antibody."
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) and was designed
specifically to block infectivity of SARS-CoV-2, the virus that
causes COVID-19. 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.
In November 2020, REGEN-COV
received Emergency Use Authorization (EUA) from the U.S. Food and
Drug Administration (FDA) for the treatment of 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. The
clinical evidence from Regeneron's outpatient trial suggests that
monoclonal antibodies such as casirivimab and imdevimab have the
greatest benefit when given early after diagnosis and in patients
who are seronegative and/or who have high viral load. 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.
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.
REGEN-COV was invented using Regeneron's
VelocImmune® technology that 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 multiple
antibodies including 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) is an investigational combination therapy and has been
authorized by FDA for the emergency use described above. REGEN-COV
is not FDA approved for any use and its safety and effectiveness
has not yet been established for the treatment of COVID-19.
This authorized use is 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.
Limitations of Authorized Use
- 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.
- 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.
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.
- Nursing Mothers: 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, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, pain, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune®, which uses unique
genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Regeneron 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 without limitation the development program
relating to REGEN-COVTM (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) and new indications for Regeneron's
Products; 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;
uncertainty of market acceptance and commercial success of
Regeneron's Products and product candidates and the impact of
studies (whether conducted by Regeneron or others and whether
mandated or voluntary) (including the study discussed in this press
release) on any potential regulatory approval (including with
respect to REGEN-COV) and/or the commercial success of Regeneron's
Products and product candidates; 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 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 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
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. 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).
Regeneron
Contacts:
Media
Relations
Sarah
Cornhill
media@regeneron.com
|
Investor
Relations
Vesna
Tosic
investor@regeneron.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.