Sanofi and Regeneron Announce FDA
Approval of Kevzara® (sarilumab)
for the Treatment of Moderately to Severely Active Rheumatoid
Arthritis in Adult Patients
-
Kevzara is now available to U.S. patients -
Paris and
Tarrytown, N.Y. - May 22, 2017 - Sanofi and Regeneron
Pharmaceuticals, Inc. today announced the U.S. Food and Drug
Administration (FDA) approval of Kevzara® (sarilumab)
for the treatment of adult patients with moderately to severely
active rheumatoid arthritis (RA) who have had an inadequate
response or intolerance to one or more disease modifying
antirheumatic drugs (DMARDs), such as methotrexate
(MTX).[1] Kevzara is
a human monoclonal antibody that binds to the interleukin-6
receptor (IL-6R), and has been shown to inhibit IL-6R mediated
signaling.1 IL-6 is a
cytokine in the body that, in excess and over time, can contribute
to the inflammation associated with RA.[2]
"In the clinical
trial program, sarilumab demonstrated statistically significant,
clinically-meaningful improvements in adult patients with
rheumatoid arthritis by reducing signs and symptoms, improving
physical function, and resulting in significantly less radiographic
progression of structural damage of RA," said Alan Kivitz,
M.D., CPI, Founder and Medical Director of the Altoona Center for
Clinical Research and Altoona Arthritis and Osteoporosis Center,
and an investigator in the global SARIL-RA clinical program for
sarilumab. "This is important because not all
currently available treatments work in all patients, and some
patients may spend years cycling through different treatments
without achieving their treatment goals. Sarilumab works
differently from the most commonly used biologics, such as those in
the anti-TNF class, and is a welcome new option for patients and
their physicians."
RA is a chronic inflammatory
autoimmune disease, which carries substantial burden. In RA, the
immune system attacks the tissues of the joints, causing
inflammation, pain, and eventually joint damage and
disability.[3] RA affects
approximately 1.3 million Americans, with nearly 75 percent being
women.[4] It most
often strikes people between 30 and 60 years old; however, it can
occur in adults at any age.[5]
"Despite the many
advances made in the treatment of rheumatoid arthritis, patients
continue to need new treatment options," said Olivier
Brandicourt, M.D., Chief Executive Officer, Sanofi. "Today's approval in the U.S. not only underscores our
ongoing commitment to making a difference in the lives of patients,
but also demonstrates our drive to accelerate science and medicine
in immunology."
"Today's
milestone with Kevzara, which follows closely on the heels of our
recent approval of Dupixent (dupilumab), showcases the ability of
our internal discovery and science engine to deliver important new
medicines by leveraging our leading technologies, such as
VelocImmune," said George D. Yancopoulos, M.D., Ph.D., Founding
Scientist, President, and Chief Scientific Officer,
Regeneron. "This milestone would not have been
possible without our important ongoing collaboration with Sanofi,
and most importantly, the patients and physicians who participated
in our SARIL-RA clinical program, and worked with us to make
Kevzara available to those in the U.S. RA community in need of new
options."
Kevzara may be used as monotherapy
or in combination with MTX or other conventional DMARDs.1
The recommended dosage of Kevzara is 200 mg once every two weeks
given as a subcutaneous injection, which can be self-administered.
The dosage can be reduced from 200 mg to 150 mg once every two
weeks, as needed, to help manage certain laboratory abnormalities
(neutropenia, thrombocytopenia, and liver enzyme
elevations).1
The approval of Kevzara was based
on data from approximately 2,900 adults with moderately to severely
active RA who had an inadequate response to previous treatment
regimens. In two pivotal Phase 3 clinical trials, Kevzara plus
background DMARDs demonstrated statistically significant,
clinically-meaningful improvements in patients with moderately to
severely active RA.[6],[7],[8],[9],[10],[11]
In the MOBILITY study, treatment
with Kevzara plus MTX reduced signs and symptoms, improved physical
function, and demonstrated significantly less radiographic
progression of structural damage, compared to placebo plus MTX.
-
At 24 weeks, patients treated with Kevzara plus
MTX achieved a greater improvement in the primary endpoint of signs
and symptoms as measured by the proportion of patients achieving a
20 percent improvement in the American College of Rheumatology
Criteria (ACR20) (Kevzara 200 mg, 66%; Kevzara 150 mg, 58%;
placebo, 33%)
-
At 52 weeks, patients treated with Kevzara plus
MTX demonstrated significantly less radiographic progression of
structural damage as measured by the change in modified Total Sharp
Score, a key endpoint of the study (placebo, 2.78; Kevzara 200 mg,
0.25; Kevzara 150 mg, 0.90)
-
At 16 weeks, patients treated with Kevzara plus
MTX demonstrated greater improvement from baseline in physical
function as measured by the Health Assessment Questionnaire -
Disability Index (HAQ-DI), a key endpoint of the study (Kevzara 200
mg, -0.58; Kevzara 150 mg, -0.54; placebo, -0.30)
In the TARGET study, treatment
with Kevzara plus DMARD reduced signs and symptoms and improved
physical function, compared to placebo plus DMARD.
-
At 24 weeks, patients treated with Kevzara plus
DMARD achieved a greater improvement in the primary endpoint of
signs and symptoms as measured by the proportion of patients
achieving an ACR20 response (Kevzara 200 mg, 61%; Kevzara 150 mg,
56%; placebo, 34%)
-
At 12 weeks, patients treated with Kevzara plus
DMARD demonstrated greater improvement from baseline in physical
function as measured by HAQ-DI, a key endpoint of the study
(Kevzara 200 mg, -0.49; Kevzara 150 mg, -0.50; placebo,
-0.29)
Patients treated with Kevzara are
at increased risk of developing serious infections that may lead to
hospitalization or death. The most common adverse reactions
(occurring in at least 3% of patients treated with Kevzara in
combination with DMARDs vs. placebo in combination with DMARDs)
observed with Kevzara in the clinical studies were neutropenia
(7-10% vs. 0.2%), increased alanine aminotransferase (5% vs. 2%),
injection site erythema (4-5% vs. 0.9%), upper respiratory
infections (3-4% vs. 2%) and urinary tract infections (3% vs.
2%).1
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. The
companies have launched KevzaraConnect®, a
comprehensive and specialized program that provides support
services to patients throughout every step of the treatment
process. KevzaraConnect will also help eligible patients who are
uninsured, lack coverage, or need assistance with their
out-of-pocket copay costs. Additionally, KevzaraConnect offers
personalized support from registered nurses and other specialists
who are available 24/7 to speak with patients and help them
navigate the complex insurance process. For more information,
please call 1-844-Kevzara (1-844-538-9272) or visit
www.Kevzara.com.
The U.S. Wholesale Acquisition
Cost (WAC) of Kevzara is $39,000/year for the 200 mg and 150 mg
doses, and is approximately 30 percent lower than the WAC for the
two most widely used TNF-alpha inhibitors. Actual costs to
patients, payers and health systems are anticipated to be lower as
WAC does not reflect discounts, rebates or copay support.
In the U.S., Kevzara will be
marketed by Regeneron and Sanofi Genzyme, the specialty care global
business unit of Sanofi. Kevzara was approved in Canada in January
2017. In April 2017, the European Medicine Agency's (EMA) Committee
for Medicinal Products for Human Use (CHMP) adopted a positive
opinion for the marketing authorization of Kevzara recommending its
approval for use in adult patients with moderately to severely
active RA. A final decision on the Marketing Authorization
Application (MAA) for Kevzara in the European Union will be made by
the European Commission in the coming months. The companies are
also seeking approvals in a number of other countries globally.
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 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.
-
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, such as sweats or chills,
muscle aches, cough, shortness of breath, blood in 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 or feel very tired; or 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.
-
TEARS (PERFORATION) OF THE
STOMACH OR INTESTINES: Some people using Kevzara get tears in
their stomach or intestine. 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 the lips, tongue or face; moderate to 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
breastmilk.
-
take any medicines, including prescription and
nonprescription medicines, vitamins, and herbal supplements.
Especially 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.
-
The most common side effects include:
-
injection site redness
-
upper respiratory tract infection
-
urinary tract infection
-
nasal congestion, sore throat, 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 negative side effects of prescription drugs to
the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088 or to
Sanofi-Aventis at 1-800-633-1610.
To learn more,
talk about Kevzara with your healthcare provider or pharmacist. The
FDA-approved Medication Guide and Prescribing Information can be
found at Kevzara.com or by calling 1-844-Kevzara
(1-844-538-9272).
Please click here for full prescribing information
including risk of SERIOUS SIDE EFFECTS and Medication
Guide
About
Sanofi
Sanofi, a global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs.
Sanofi is organized into five global business units: Diabetes and
Cardiovascular, General Medicines and Emerging Markets, Sanofi
Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed
in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
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often difficult to diagnose and treat, providing hope to patients
and their families.
About Regeneron
Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based
biopharmaceutical company that discovers, invents, develops,
manufactures and commercializes medicines for the treatment of
serious medical conditions. All Regeneron commercialized medicines
were discovered and developed by our own scientists, including
therapies for eye diseases, high LDL cholesterol, atopic
dermatitis, rheumatoid arthritis, and a rare inflammatory
condition. Regeneron also has product candidates in development in
other areas of high unmet medical need, including asthma, pain,
cancer and infectious diseases. Regeneron invented the leading
VelociSuite® technologies,
which are a suite of complementary genetics-based technologies that
accelerate, improve and disrupt the traditional drug discovery and
development process and established the Regeneron Genetics Center,
one of the largest genetic sequencing efforts in the world. For
additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
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for the treatment of adult patients with moderately to severely
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[1] Kevzara
(sarilumab) Prescribing Information. May 2017
[2] Gibofsky,
A. Overview of Epidemiology, Pathophysiology, and Diagnosis of
Rheumatoid Arthritis. Am J Manag Care. 2012 Dec;18(13
Suppl):S295-302.
[3] Mayo
Clinic. "Rheumatoid Arthritis." Available at
http://www.mayoclinic.org/diseases-conditions/rheu1natoid-arthritis/basics/definition/con-20014868.
Last accessed May 2017.
[4] American
College of Rheumatology. "Rheumatoid Arthritis." Available at:
http://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis.
Last accessed: May 2017.
[5] Arthritis
Foundation. "What is Rheumatoid Arthritis." Available at:
http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php.
Last accessed May 2017.
[6] Genovese,
MC. Sarilumab Plus Methotrexate in Patients With Active Rheumatoid
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Phase III Study. Arthritis Rheumatology. 2015
Jun 67(6):1424-37.
[7]
Fleischmann, R. Sarilumab and Non-Biologic Disease-Modifying
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10.1002/art.39944.
[8] Sanofi. To
Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In
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ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of
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https://clinicaltrials.gov/ct2/show/NCT02057250 NLM Identifier:
NCT02057250.
[9] Emery P,
Rondon J, Garg A, et al. Safety and tolerability of subcutaneous
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[10] Burmester
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[11] Sanofi. To
Evaluate the Immunogenicity and Safety of Sarilumab Administered as
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National Library of Medicine (US). 2000- [cited May 2017].
Press Release
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Source: Sanofi via Globenewswire
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