TARRYTOWN, N.Y., Nov. 21, 2020 /PRNewswire/ --
First treatment of any kind to have prospectively confirmed
and statistically significant anti-viral activity against
SARS-CoV-2
Authorized for recently diagnosed, mild to moderate COVID-19
in high-risk patients
Initial doses of REGEN-COV2 will be made available to
approximately 300,000 patients, with no medication out-of-pocket
costs, under U.S. government allocation program
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
that the antibody cocktail casirivimab and imdevimab administered
together (also known as REGN-COV2 or REGEN-COV2), a therapy
currently being investigated for use in COVID-19, has received
Emergency Use Authorization (EUA) from the U.S. Food and Drug
Administration (FDA). Casirivimab and imdevimab administered
together are authorized 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 REGEN-COV2 have the greatest benefit
when given early after diagnosis and in patients who have not yet
mounted their own immune response or who have high viral load.
The criteria for 'high-risk' patients are described in the Fact
Sheet for Health Care Providers. Casirivimab and imdevimab are not
authorized for use in patients who are hospitalized or require
oxygen therapy due to COVID-19, 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 FDA Emergency Use Authorization is an important step in
the fight against COVID-19, as high-risk patients in the United States will have access to a
promising therapy early in the course of their infection," said
Leonard S. Schleifer, M.D., Ph.D.,
President and Chief Executive Officer of Regeneron. "The science
and technology investments Regeneron has made over three decades
positioned us to move rapidly to invent, study and maximize
production of REGEN-COV2. Even with these incredible efforts,
demand may exceed supply initially, making it even more critical
that federal and state governments ensure REGEN-COV2 is distributed
fairly and equitably to the patients most in need. In the first
quarter of 2021, we expect to increase available REGEN-COV2 global
supply as we continue our collaboration with Roche."
"REGEN-COV2 is designed to mimic what a well-functioning immune
system does by using very potent antibodies to neutralize the
virus," said George D. Yancopoulos,
M.D., Ph.D., President and Chief Scientific Officer of Regeneron.
"Data from approximately 800 non-hospitalized patients showed
significant reductions in virus levels within days of receiving
REGEN-COV2, which were associated with significantly fewer medical
visits. This benefit was greatest in patients most at risk for poor
outcomes due to high viral load, ineffective immune response at
baseline or pre-existing risk factors. We are encouraged that no
variants resistant to the cocktail were identified in the clinical
trial analyses to date, which is consistent with our preclinical
findings. We are also very encouraged by recently announced
promising vaccine results; however, there remains a need to treat
patients who develop COVID-19, especially as some may not have had
access to or were not protected by vaccination. Importantly, we
continue to advance our rigorous clinical trial program evaluating
the safety and efficacy of REGEN-COV2 for both the treatment and
prevention of COVID-19, and we will share new results as
available."
Production of monoclonal antibodies is a complex, time- and
labor-intensive process that requires deep expertise. Utilizing
production and manufacturing platforms developed over decades,
Regeneron rapidly scaled up REGEN-COV2, beginning in the early days
of the pandemic with support from the Biomedical Advanced Research
and Development Authority (BARDA), part of the Office of the
Assistant Secretary for Preparedness and Response at the U.S.
Department of Health and Human Services. Regeneron now expects to
have REGEN-COV2 treatment doses ready for approximately 80,000
patients by the end of November, approximately 200,000 patients by
the first week of January, and approximately 300,000 patients
in total by the end of January 2021.
As part of Operation Warp Speed, in July the U.S. government and
Regeneron signed an agreement for this initial supply of
REGEN-COV2. The U.S. government will coordinate with state
authorities to allocate REGEN-COV2 on a weekly basis based on the
number of COVID-19 cases in each state. The government has
committed to providing these 300,000 doses at no cost to patients,
although healthcare facilities may charge fees related to
administration. Regeneron will immediately begin shipping
REGEN-COV2 to Amerisource Bergen, a national distributor, which
will distribute the therapy as directed by the government.
Under the EUA, the recommended dose is 1,200 mg of casirivimab
and 1,200 mg of imdevimab (2,400 mg total) administered as a single
intravenous infusion. The authorization is based on positive Phase
2 data announced in September and October from the first 799 adults
in an ongoing randomized, double-blind, placebo-controlled trial of
non-hospitalized patients ("outpatients") with COVID-19.
The FDA grants Emergency Use Authorization to medicines that may
help diagnose, treat or prevent a life-threatening disease when
adequate and approved alternatives are not available. The EUA is
temporary and does not take the place of a formal biologics license
application (BLA) submission review and approval process. This use
is authorized only for the duration of the declaration that
circumstances exist justifying the authorization of the emergency
use, unless terminated or revoked sooner. Casirivimab and imdevimab
have not been approved by FDA and remain investigational.
Evaluation of its safety and efficacy is ongoing in multiple
clinical trials. Data from these trials will be used to support a
future BLA submission. Health care providers should review the Fact
Sheet for detailed information on the authorized use and
requirements of the EUA and may call 844-734-6643 for more
information. Please see the Fact Sheet and FDA Letter of
Authorization at http://www.regencov2.com/.
REGEN-COV2 continues to be evaluated in Phase 2/3 clinical
trials for the treatment of COVID-19 in certain hospitalized and
non-hospitalized patients, the Phase 3 open-label RECOVERY trial of
hospitalized patients in the UK, and a Phase 3 trial for
the prevention of COVID-19 in household contacts of infected
individuals. To date, more than 7,000 people have participated in
REGEN-COV2 clinical trials.
About REGEN-COV2
REGEN-COV2 is a cocktail of two
monoclonal antibodies (casirivimab and imdevimab, also known as
REGN10933 and REGN10987, respectively) and was designed
specifically to block infectivity of SARS-CoV-2, the virus that
causes COVID-19.
To develop REGEN-COV2, Regeneron scientists evaluated
thousands of fully-human antibodies produced by the company's
VelocImmune® mice, which have been genetically
modified to have a human immune system, as well as antibodies
identified from humans who have recovered from COVID-19. The two
potent, virus-neutralizing antibodies that form REGEN-COV2 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.
REGEN-COV2's development and manufacturing has been funded in
part with federal funds from BARDA under OT number:
HHSO100201700020C. Regeneron continues to increase in-house
production of REGEN-COV2, and the company has partnered with
Roche to increase the global supply of REGEN-COV2 beginning in
2021. If REGEN-COV2 proves safe and effective in clinical trials
and regulatory approvals are granted, Regeneron will manufacture
and distribute it in the U.S. and Roche will develop, manufacture
and distribute it outside the U.S. Once both companies are at
full manufacturing capacity in 2021, there are expected to be at
least 2 million treatment doses available annually.
AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION
Authorized Emergency Use
Casirivimab and imdevimab injection (REGEN-COV2) is an
investigational combination therapy and has been authorized by FDA
for the emergency use described above. Casirivimab and imdevimab
injection is not FDA approved for any use. Safety and effectiveness
of casirivimab and imdevimab injection have 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
- Casirivimab and imdevimab injection 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 casirivimab and imdevimab injection
has not been observed in patients hospitalized due to COVID-19.
Monoclonal antibodies, such as casirivimab and imdevimab, may be
associated with worse clinical outcomes when administered to
hospitalized patients requiring high flow oxygen or mechanical
ventilation with COVID-19.
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, OR
- sickle cell disease, OR
- congenital or acquired heart disease, OR
- neurodevelopmental disorders, for example, 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 casirivimab
and imdevimab injection. 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 casirivimab and imdevimab
injection. Signs and symptoms of infusion related reactions may
include fever, chills, nausea, headache, bronchospasm, hypotension,
angioedema, throat irritation, rash including urticaria, pruritus,
myalgia, and/or dizziness. If an infusion-related reaction occurs,
consider slowing or stopping the infusion and administer
appropriate medications and/or supportive care.
- Limitations of Benefit and Potential for Risk in Patients
with Severe COVID-19: Benefit of treatment with casirivimab and
imdevimab injection has not been observed in patients hospitalized
due to COVID-19. Monoclonal antibodies, such as casirivimab and
imdevimab, may be associated with worse clinical outcomes when
administered to hospitalized patients requiring high flow oxygen or
mechanical ventilation with COVID-19. Therefore, casirivimab and
imdevimab injection is not authorized for use in 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 the casirivimab and imdevimab injection 2,400 mg group,
2 (0.8%) patients in casirivimab and imdevimab injection 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 casirivimab and
imdevimab injection), intestinal obstruction and dyspnea (8,000 mg
casirivimab and imdevimab injection) and COVID-19, pneumonia and
hypoxia (placebo). Casirivimab and imdevimab injection are not
authorized at the 8,000 mg dose (4,000 mg casirivimab and 4,000 mg
imdevimab).
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 casirivimab and imdevimab injection in
COVID-19 patients who are pregnant. Casirivimab and imdevimab
injection 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 casirivimab and imdevimab injection 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 casirivimab and imdevimab injection and
any potential adverse effects on the breastfed child from
casirivimab and imdevimab injection 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 eight
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.
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 (including those discussed in this press release),
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-COV2 (Regeneron's investigational multi-antibody
therapy for the treatment and prevention of COVID-19); how long the
Emergency Use Authorization ("EUA") granted by the U.S. Food and
Drug Administration (the "FDA") for REGEN-COV2 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-COV2) and
new indications for Regeneron's Products; safety issues resulting
from the administration of Regeneron's Products and product
candidates (such as REGEN-COV2) in patients, including serious
complications or side effects in connection with the use of
Regeneron's Products and product candidates in clinical trials
(including those discussed in this press release); the ability of
Regeneron to manufacture in anticipated quantities Regeneron's
Products and product candidates, including REGEN-COV2; the ability
of Regeneron to manage supply chains for multiple products and
product candidates; 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; 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 trials discussed in
this press release, on any potential regulatory approval (including
with respect to REGEN-COV2) 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-COV2; 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-COV2, 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), and Praluent®
(alirocumab)), 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, 2019 and its Form
10-Q for the quarterly period ended September 30, 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).
Contacts:
Media Relations
Alexandra
Bowie
Tel: +1 (914) 847-3407
alexandra.bowie@regeneron.com
Investor Relations
Mark
Hudson
Tel: +1 (914) 847-3482
mark.hudson@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.