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).
Sanofi Genzyme focuses on developing specialty
treatments for debilitating diseases that are 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
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severely active rheumatoid arthritis who have had an inadequate
response or intolerance to one or more disease modifying
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the opinion adopted by the European Medicine Agency's Committee for
Medicinal Products for Human Use referenced in this news release on
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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 Arthritis and
Inadequate Response to Methotrexate: Results of a Phase III Study.
Arthritis Rheumatology. 2015 Jun 67(6):1424-37. [7] Fleischmann, R.
Sarilumab and Non-Biologic Disease-Modifying Antirheumatic Drugs in
Patients With Active RA and Inadequate Response or Intolerance to
TNF Inhibitors. Arthritis Rheumatology. 2016 Nov 10.1002/art.39944.
[8] Sanofi. To Evaluate Sarilumab - SAR153191 (REGN88) -
Auto-injector Device In Patients With Rheumatoid Arthritis
(SARIL-RA-EASY). In: ClinicalTrials.gov [Internet]. Bethesda (MD):
National Library of Medicine (US). 2000- [cited May 2017].
Available from: https://clinicaltrials.gov/ct2/show/NCT02057250 NLM
Identifier: NCT02057250. [9] Emery P, Rondon J, Garg A, et al.
Safety and tolerability of subcutaneous sarilumab compared to
intravenous tocilizumab in patients with RA. Arthritis
Rheumatol. 2015;67(suppl 10): 971. [10] Burmester G, Garg A, van
Hoogstraten H, et al. Sarilumab dose reduction to manage laboratory
abnormalities in an open-label extension study in RA
patients. Arthritis Rheumatol. 2015;67 (suppl 10): 2762.
[11] Sanofi. To Evaluate the Immunogenicity and Safety of Sarilumab
Administered as Monotherapy in Patients With Rheumatoid Arthritis
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(MD): National Library of Medicine (US). 2000- [cited May
2017].
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