TARRYTOWN, N.Y. and
PARIS, July
2, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) and Sanofi
today announced that the U.S. Phase 3 trial of
Kevzara® (sarilumab) 400 mg in COVID-19 patients
requiring mechanical ventilation did not meet its primary and key
secondary endpoints when Kevzara was added to best supportive care
compared to best supportive care alone (placebo).
Minor positive trends were observed in the primary pre-specified
analysis group (critical patients on Kevzara 400 mg who were
mechanically ventilated at baseline) that did not reach statistical
significance, and these were countered by negative trends
in a subgroup of critical patients who were not mechanically
ventilated at baseline.1 In the primary analysis
group, adverse events were experienced by 80% of Kevzara patients
and 77% of placebo patients. Serious adverse events that
occurred in at least 3% of patients and more frequently among
Kevzara patients were multi-organ dysfunction syndrome (6% Kevzara,
5% placebo) and hypotension (4% Kevzara, 3% placebo).
Based on the results, the U.S.-based trial has been stopped,
including in a second cohort of patients who received a higher dose
of Kevzara (800 mg). Detailed results will be submitted to a
peer-reviewed publication later this year.
The primary analysis group included 194 patients who were
critically ill with COVID-19 and were receiving mechanical
ventilation at the time of enrollment. The primary endpoint
assessed the percentage of patients who achieved at least a 1-point
change from baseline on a 7-point scale, which consisted of 1)
death; 2) hospitalized, requiring invasive mechanical ventilation
or extracorporeal membrane oxygenation (ECMO); 3) hospitalized,
requiring non-invasive ventilation or high-flow oxygen devices; 4)
hospitalized, requiring supplemental oxygen; 5) hospitalized, not
requiring supplemental oxygen – requiring ongoing medical care
(COVID-19 related or otherwise); 6) hospitalized, not requiring
supplemental oxygen – no longer requires ongoing medical care; 7)
discharged from hospital. A second cohort, which was partially
recruited (n=27), compared Kevzara 800 mg versus placebo.
The Kevzara trial was designed after a small (n=21), single-arm
study in China (Xu et al) among mostly severe, febrile,
hospitalized COVID-19 patients found elevated IL-6 levels and
suggested that inhibiting this pathway with the IL-6 blocker
tocilizumab rapidly reduced fever and improved oxygenation in
severe patients, allowing for successful hospital discharge. The
Phase 3 Kevzara trial was designed to evaluate this hypothesis in a
large, placebo-controlled trial. The trial has been funded in part
with federal funds from the Department of Health and Human
Services; Office of the Assistant Secretary for Preparedness and
Response; and Biomedical Advanced Research and Development
Authority (BARDA), under OT number: HHSO100201700020C.
A separate Sanofi-led trial outside of the U.S. in hospitalized
patients with severe and critical COVID-19 using a different dosing
regimen is ongoing. The same Independent Data Monitoring Committee
(IDMC) is overseeing both the Regeneron-led U.S. trial and the
Sanofi-led trial outside of U.S. and has recommended that the trial
outside of the U.S. continue. The companies expect to report
results of the trial outside of the U.S. in Q3 2020.
Footnote
- Clinical trial endpoints that showed positive trends in
patients on mechanical ventilation at baseline, and were
countered by negative trends in patients who were not
mechanically ventilated at baseline included: the proportion
of patients with a 1-point improvement on day 22 (primary endpoint
for mechanical ventilation group); the proportion of patients who
died by day 29; and the proportion of patients who recovered by day
22.
About Kevzara® (sarilumab)
Injection
Kevzara is currently approved in multiple
countries to treat adults with moderately to severely active
rheumatoid arthritis who have not responded to or tolerated
previous therapy.
Kevzara binds specifically to the IL-6 receptor, and has been
shown to inhibit IL-6-mediated signaling. IL-6 is an immune system
protein produced in increased quantities in patients with
rheumatoid arthritis and has been associated with disease activity,
joint destruction and other systemic problems. Kevzara is being
investigated for its ability to reduce the overactive inflammatory
immune response associated with COVID-19 based on evidence of
markedly elevated levels of IL-6 in critically ill patients
infected with coronaviruses.
IMPORTANT SAFETY INFORMATION FOR KEVZARA®
(sarilumab) INJECTION
KEVZARA can cause serious side effects including:
- SERIOUS INFECTIONS: KEVZARA is a medicine that
affects your immune system. KEVZARA can lower the ability of your
immune system to fight infections. Some people have serious
infections while using KEVZARA, including tuberculosis (TB), and
infections caused by bacteria, fungi, or viruses that can spread
throughout the body. Some people have died from these
infections. Your healthcare provider should test you for TB
before starting KEVZARA. Your healthcare provider should monitor
you closely for signs and symptoms of TB during treatment with
KEVZARA.
-
- Before starting KEVZARA, tell your healthcare provider if
you:
-
- think you have an infection or have symptoms of an infection,
with or without a fever. Symptoms may include sweats or chills,
muscle aches, a cough, shortness of breath, blood in your phlegm,
weight loss, warm, red, or painful skin or sores on your body,
diarrhea or stomach pain, burning when you urinate or urinating
more often than normal, if you feel very tired, or if you are being
treated for an infection, get a lot of infections or have repeated
infections
- have diabetes, HIV, or a weakened immune system
- have TB, or have been in close contact with someone with
TB
- live or have lived, or have traveled to certain parts of the
country (such as the Ohio and
Mississippi River valleys and the Southwest) where there is an
increased chance of getting certain fungal infections
(histoplasmosis, coccidioidomycosis, or blastomycosis)
- have or have had hepatitis
- After starting KEVZARA, call your healthcare provider right
away if you have any symptoms of an infection.
- CHANGES IN CERTAIN LABORATORY TEST RESULTS: Your
healthcare provider should do blood tests before and after starting
KEVZARA to check for low neutrophil (white blood cells that help
the body fight off bacterial infections) counts, low platelet
(blood cells that help with blood clotting and stop bleeding)
counts, and an increase in certain liver function tests. Changes in
test results are common with KEVZARA and can be severe. You
may also have changes in other laboratory tests, such as your blood
cholesterol levels. Your healthcare provider should do blood tests
4 to 8 weeks after starting KEVZARA and then every 6 months during
treatment to check for an increase in blood cholesterol
levels.
-
- TEARS (PERFORATION) OF THE STOMACH OR INTESTINES: Tell
your healthcare provider if you have had a condition known as
diverticulitis (inflammation in parts of the large intestine) or
ulcers in your stomach or intestines. Some people using KEVZARA had
tears in their stomach or intestine. This happens most often in
people who also take nonsteroidal anti-inflammatory drugs (NSAIDS),
corticosteroids, or methotrexate. Call your healthcare provider
right away if you have fever and stomach (abdominal) pain that does
not go away.
- CANCER: KEVZARA may increase your risk of certain
cancers by changing the way your immune system works. Tell
your healthcare provider if you have ever had any type of
cancer.
- SERIOUS ALLERGIC REACTIONS: Serious allergic reactions
can happen with KEVZARA. Get medical attention right away if
you have any of the following signs: shortness of breath or trouble
breathing; feeling dizzy or faint; swelling of your lips, tongue or
face; moderate or severe stomach (abdominal) pain or vomiting; or
chest pain.
- Do not use KEVZARA if you are allergic to Sarilumab or any of
the ingredients of KEVZARA.
- Before using KEVZARA, tell your healthcare provider if you
-
- have an infection
- have liver problems
- have had stomach (abdominal) pain or a condition known as
diverticulitis (inflammation in parts of the large intestine) or
ulcers in your stomach or intestines
- recently received or are scheduled to receive a vaccine. People
who take KEVZARA should not receive live vaccines
- plan to have surgery or a medical procedure
- are pregnant or plan to become pregnant. It is not known if
KEVZARA will harm your unborn baby
- are breastfeeding or plan to breastfeed. Talk to your
healthcare provider about the best way to feed your baby if you use
KEVZARA. It is not known if KEVZARA passes into your breast
milk
- take any prescription or nonprescription medicines, vitamins or
herbal supplements. It is especially important to tell your
healthcare provider if you use any other medicines to treat your
RA. Using KEVZARA with these medicines may increase
your risk of infection
- medicines that affect the way certain liver enzymes work. Ask
your healthcare provider if you are not sure if your medicine is
one of these
- The most common side effects include:
-
- injection site redness
- upper respiratory tract infection
- urinary tract infection
- nasal congestion, sore throat, and runny nose
These are not all the possible side effects of
KEVZARA. Tell your doctor about any side effect that
bothers you or does not go away. You are encouraged to report side
effects of prescription drugs to the FDA at
www.fda.gov/medwatch or call 1-800-FDA-1088.
WHAT IS KEVZARA?
Kevzara is an injectable prescription medicine called an
interleukin-6 (IL-6) receptor blocker. Kevzara is used to treat
adult patients with moderately to severely active rheumatoid
arthritis (RA) after at least one other medicine called a
disease-modifying antirheumatic drug (DMARD) has been used and did
not work well or could not be tolerated.
Click here for full Prescribing Information including risk
of SERIOUS SIDE EFFECTS and Medication Guide for KEVZARA.
About Regeneron Pharmaceuticals, Inc.
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 seven 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.
About Sanofi
Sanofi is dedicated to supporting people
through their health challenges. We are a global biopharmaceutical
company focused on human health. We prevent illness with vaccines,
provide innovative treatments to fight pain and ease suffering. We
stand by the few who suffer from rare diseases and the millions
with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
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, 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 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 Kevzara® (sarilumab) for the treatment of
hospitalized patients with severe or critical respiratory illness
caused by COVID-19 and REGN-COV2 (Regeneron's investigational dual
antibody cocktail for the prevention and treatment of COVID-19);
the likelihood, timing, and scope of possible regulatory approval
and commercial launch of Regeneron's product candidates and new
indications for Regeneron's Products; unforeseen safety issues
resulting from the administration of Regeneron's Products and
product candidates (such as Kevzara and REGN-COV2) 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 without limitation
Kevzara and REGN-COV2; ongoing regulatory obligations and oversight
impacting Regeneron's Products (such as Kevzara), research and
clinical programs, and business, including those relating to
patient privacy; 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) on the commercial success of
Regeneron's Products and product candidates; 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 Regeneron's Products and
product candidates; the extent to which the results from the
research and development programs conducted by Regeneron or its
collaborators may be replicated in other studies and lead to
therapeutic applications; the ability of Regeneron to manufacture
and 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;
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 or collaboration agreement, including Regeneron's
agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries
Ltd.(or their respective affiliated companies, as applicable), to
be cancelled or terminated without any further product success; 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 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 March
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 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).
Sanofi Forward-Looking Statements
This press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial
results, events, operations, services, product development and
potential, and statements regarding future performance.
Forward-looking statements are generally identified by the words
"expects", "anticipates", "believes", "intends", "estimates",
"plans" and similar expressions. Although Sanofi's management
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi's
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such litigation,
trends in exchange rates and prevailing interest rates, volatile
economic and market conditions, cost containment initiatives and
subsequent changes thereto, and the impact that COVID-19 will have
on us, our customers, suppliers, vendors, and other business
partners, and the financial condition of any one of them, as well
as on our employees and on the global economy as a whole. Any
material effect of COVID-19 on any of the foregoing could also
adversely impact us. This situation is changing rapidly and
additional impacts may arise of which we are not currently aware
and may exacerbate other previously identified risks. The risks and
uncertainties also include the uncertainties discussed or
identified in the public filings with the SEC and the AMF made by
Sanofi, including those listed under "Risk Factors" and "Cautionary
Statement Regarding Forward-Looking Statements" in Sanofi's annual
report on Form 20-F for the year ended December 31, 2019. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Regeneron
Contacts:
|
Sanofi
Contacts:
|
|
|
Media
Relations
Sarah
Cornhill
Tel: +1 (914)
847-5018
sarah.cornhill@regeneron.com
|
Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
ashleigh.koss@sanofi.com
|
|
|
Investor
Relations
Vesna
Tosic
Tel: +1 (914)
847-5443
Vesna.Tosic@regeneron.com
|
Investor
Relations
Felix
Lauscher
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.