TARRYTOWN, N.Y., Feb. 26, 2021 /PRNewswire/ --
EU member states can utilize the positive CHMP opinion when
making national decisions about use of the antibody cocktail, prior
to a potential future EMA market authorization
Regeneron has collaborated with Roche to develop and
manufacture the antibody cocktail; Roche is responsible ex-U.S. and
has already begun distribution in the EU
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
the European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) has issued a positive opinion for the
company's investigational COVID-19 antibody cocktail (casirivimab
with imdevimab). The CHMP recommends that the antibody cocktail,
known as REGEN-COVTM in the U.S., can be used to treat
confirmed COVID-19 in patients who do not require supplemental
oxygen and who are at high risk of progressing to severe
COVID-19.
"Today's endorsement by the EU's leading scientific body for
medicines helps bring our antibody cocktail one step closer to even
more COVID-19 patients who could benefit from it," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer at Regeneron. "Our
collaborator Roche is already in active discussions with a number
of European countries following release of our data in
non-hospitalized patients that showed the antibody cocktail
significantly reduced virus levels within days of treatment, which
was associated with significantly fewer medical visits. This is
supported by preclinical data that show that our antibody cocktail
effectively neutralizes emerging strains of the virus, which are
becoming increasingly common in Europe and around the world."
The CHMP recommendation provides a harmonized, European
Union (EU)-level opinion on the efficacy, quality and safety of the
antibody cocktail, which can be used by EU member states when
making decisions on the possible use of the antibody cocktail at a
national level prior to a market authorization. Under Article 5(3)
of Regulation EC 726/2004, the CHMP assessed available data in
non-hospitalized patients ("outpatients") with COVID-19 as well as
supportive data from other settings.
The CHMP's review took place in parallel to the EMA's ongoing
rolling review process, which is used to speed up the formal
marketing application assessment of a promising medicine during a
public health emergency. Once finalized it will be the basis for an
EU marketing authorization for the antibody cocktail. Regeneron,
together with Roche, continues to work closely with the EMA as it
undertakes its rolling review.
Regeneron is collaborating with Roche to increase global
supply of the antibody cocktail. 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., with the first Roche-manufactured doses already
being distributed. 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.
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 Antibody Cocktail
The antibody cocktail, known as REGEN-COV (casirivimab with
imdevimab) in the U.S., consists 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.
REGEN-COV continues to be evaluated in clinical trials in
multiple settings for COVID-19: in non-hospitalized and certain
hospitalized patients, including the open-label RECOVERY trial of
hospitalized patients in the UK, and a trial for the prevention of
COVID-19 in household contacts of infected individuals. As of
February 2021, approximately 23,000
people have participated in clinical trials involving REGEN-COV.
Lower doses of REGEN-COV are also being studied with the aim of
increasing the number of patients who could potentially be treated
if the cocktail is approved.
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); 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, including the impact of the positive opinion issued by
the European Medicines Agency's Committee for Medicinal Products
for Human Use discussed in this press release on any potential
regulatory approval of REGEN-COV; 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 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 studies discussed or
referenced 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.