Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the U.S. Food and Drug Administration has approved
Kevzara® (sarilumab) for the treatment of patients weighing 63 kg
or greater with active polyarticular juvenile idiopathic arthritis
(pJIA), a form of arthritis that impacts multiple joints at a time.
“Polyarticular juvenile idiopathic arthritis can be a painful
disease for children where multiple joints are impacted by this
chronic infammation,” said George D. Yancopoulos, M.D., Ph.D.,
Board co-Chair, President and Chief Scientific Officer at
Regeneron. "Not only are their daily lives impacted, but their
futures can be disrupted without adequate treatment. The approval
of Kevzara in polyarticular juvenile idiopathic arthritis provides
these vulnerable patients and their families a new FDA-approved
treatment option to help navigate this disease.”
The FDA approval in this patient population is supported by
evidence from adequate and well-controlled studies and
pharmacokinetic data from adults with rheumatoid arthritis as well
as a pharmacokinetic, pharmacodynamic, dose finding and safety
study in pediatric patients with pJIA.
People living with pJIA may experience joint symptoms such as
pain, stiffness and swelling, which may restrict their activities
and make certain aspects of their day-to-day life incredibly
challenging. The disease can lead to an increased risk of permanent
joint damage as well as delayed growth and development, due to
chronic joint inflammation.
No new adverse reactions (ARs) and safety concerns were
identified in the pJIA population compared to the rheumatoid
arthritis population. The most common adverse drug reactions for
patients with pJIA were nasopharyngitis, neutropenia, upper
respiratory tract infection, and injection site erythema. The most
common AR that resulted in permanent discontinuation of therapy
with Kevzara was neutropenia. Overall, patients treated with
Kevzara are at increased risk for developing serious infections
that may lead to hospitalization or death.
“This latest approval for Kevzara brings a new treatment option
with an established efficacy and safety profile to pediatric
patients living with polyarticular juvenile idiopathic arthritis,”
said Brian Foard, Executive Vice President, Head, Specialty Care at
Sanofi. “This milestone highlights our ongoing commitment to
bringing medicines to our younger patients living with this chronic
condition that can cause debilitating joint pain and
inflammation.”
Sanofi and Regeneron are committed to helping patients in the
U.S. who are prescribed Kevzara gain access to the medicine and
receive the support they may need. KevzaraConnect®, a comprehensive
and specialized program that provides support services to patients
throughout every step of the treatment process, can help eligible
patients who are uninsured, lack coverage, or need copay
assistance. For more information, please call: 1-844-Kevzara
(1-844-538-9272) or visit www.Kevzara.com.
About KevzaraIn addition to pJIA, Kevzara is
currently approved in 25 countries to treat adults with moderately
to severely active rheumatoid arthritis 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.
Kevzara is also approved in the U.S. for the treatment of
polymyalgia rheumatica – an inflammatory rheumatic disease – in
adult patients who have had an inadequate response to
corticosteroids or who cannot tolerate corticosteroid taper.
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.
Sarilumab is being jointly developed by Sanofi and Regeneron
under a global collaboration agreement.
About Regeneron's
VelocImmune®
TechnologyRegeneron'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 a
substantial proportion of all original, FDA-approved or authorized
fully human monoclonal antibodies. This includes REGEN-COV®
(casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo®
(cemiplimab-rwlc), Praluent® (alirocumab), Kevzara, Evkeeza®
(evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and
odesivimab-ebgn) and Veopoz® (pozelimab-bbfg).
U.S. Indications and Important Safety
Information
KEVZARA® (sarilumab) 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.
- adult patients with polymyalgia rheumatica (PMR) after
corticosteroids have been used and did not work well or when a slow
decrease in the dose of corticosteroids (taper) cannot be
tolerated.
- people with active polyarticular juvenile idiopathic arthritis
(pJIA) who weigh 63kg (139 lbs) or more.
It is not known if KEVZARA is safe and effective in children
with pJIA under 2 years of age.
IMPORTANT SAFETY INFORMATION
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 had 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 or your child 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
signs or symptoms of an infection, with or without a fever such as:
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 or your child’s 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 or
your child’s 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 get 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 or your child 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 or your
child are allergic to sarilumab or any of the ingredients of
KEVZARA.
- Before you or your child use KEVZARA,
tell your healthcare provider if you or your child:
- 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.
- All vaccines should be brought up-to-date before starting
KEVZARA, unless urgent treatment initiation is required.
- 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 prescription or nonprescription
medicines, vitamins, or herbal supplements. It is especially
important to tell your healthcare provider if you or your child
use.
- any other medicines to treat your
RA, PMR, or pJIA. 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
- injection site itching
- upper respiratory tract
infection
- urinary tract infection
- nasal congestion, sore throat, and
runny nose
These are not
all of 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 http://www.fda.gov/medwatch
or call 1-800-FDA-1088.
To learn more, talk about KEVZARA with your healthcare provider
or pharmacist. The FDA-approved Medication Guide and Prescribing
Information can be found at www.KEVZARA.com or by calling 1-844-
KEVZARA.
Please click here
to see full
Prescribing Information
including risk
of SERIOUS SIDE EFFECTS
and Medication Guide.
About RegeneronRegeneron (NASDAQ: REGN) is a
leading biotechnology company that invents, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led for over 35 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to numerous
FDA-approved treatments and 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, hematologic conditions,
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 more information, please visit www.Regeneron.com or follow
Regeneron on LinkedIn.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across the world, is
dedicated to transforming the practice of medicine by working to
turn the impossible into the possible. We provide potentially
life-changing treatment options and life-saving vaccine protection
to millions of people globally, while putting sustainability and
social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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 nature, timing, and possible success and
therapeutic applications of products marketed or otherwise
commercialized by Regeneron and/or its collaborators or licensees
(collectively, “Regeneron’s Products”) and product candidates being
developed by Regeneron and/or its collaborators or licensees
(collectively, “Regeneron’s Product Candidates”) and research and
clinical programs now underway or planned, including without
limitation Kevzara® (sarilumab) for the treatment of children and
adolescents two years and older with active polyarticular-course
juvenile idiopathic arthritis; uncertainty of the utilization,
market acceptance, and commercial success of Regeneron’s Products
and Regeneron’s 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 of the foregoing; the likelihood, timing, and
scope of possible regulatory approval and commercial launch of
Regeneron’s Product Candidates and new indications for Regeneron’s
Products, such as Kevzara for for the treatment of children and
adolescents 1 year and older with systemic juvenile idiopathic
arthritis; the ability of Regeneron’s collaborators, licensees,
suppliers, or other third parties (as applicable) to perform
manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron’s Products and
Regeneron’s Product Candidates; the ability of Regeneron to manage
supply chains for multiple products and product candidates; safety
issues resulting from the administration of Regeneron’s Products
(such as Kevzara) and Regeneron’s Product Candidates in patients,
including serious complications or side effects in connection with
the use of Regeneron’s Products and Regeneron’s 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 Regeneron’s Product Candidates; 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 Regeneron’s Product Candidates; the extent
to which the results from the research and development programs
conducted by Regeneron and/or its collaborators or licensees 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 and Bayer
(or their respective affiliated companies, as applicable) to be
cancelled or terminated; the impact of public health outbreaks,
epidemics, or pandemics (such as the COVID-19 pandemic) on
Regeneron's business; 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), other litigation and other proceedings and government
investigations relating to the Company and/or its operations
(including the pending civil proceedings initiated or joined by the
U.S. Department of Justice and the U.S. Attorney's Office for the
District of Massachusetts), 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, 2023 and its Form 10-Q for the quarterly
period ended March 31, 2024. 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 (https://investor.regeneron.com) and its
LinkedIn page
(https://www.linkedin.com/company/regeneron-pharmaceuticals).
Sanofi Forward-Looking StatementsThis 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 regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. 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
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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
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statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
be commercially successful, the uncertainties inherent in research
and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
marketing, unexpected safety, quality or manufacturing issues,
competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
litigation, and volatile economic and market conditions, and the
impact that pandemics or other global crises may 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. 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
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Contacts:RegeneronMedia
RelationsMary HeatherTel: +1
914-847-8650mary.heather@regeneron.com |
Investor RelationsVesna TosicTel: +1
914-847-5443vesna.tosic@regeneron.com |
Sanofi
Media RelationsSandrine GuendoulTel: 33 6 25 09 14
25sandrine.guendoul@sanofi.comEvan Berland Tel: +1 215 432
0234evan.berland@sanofi.comTimothy GilbertTel: + 1 516 521
2929timothy.gilbert@sanofi.com |
Investor RelationsThomas Kudsk LarsenTel: +44 7545
513 693 thomas.larsen@sanofi.comAlizé KaisserianTel: + 33 6 47 04
12 11alize.kaisserian@sanofi.comArnaud Delépine Tel: + 33 6 73 69
36 93arnaud.delepine@sanofi.comCorentine DriancourtTel: + 33 6 40
56 92 21corentine.driancourt@sanofi.comFelix LauscherTel: + 1
908 612 7239felix.lauscher@sanofi.comTarik ElgoutniTel:
+ 1 617 710 3587tarik.elgoutni@sanofi.comNathalie Pham Tel: + 33 7
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