Sanofi and Regeneron Announce
Approval of Kevzara® (sarilumab)
to Treat Adult Patients with Moderately to Severely Active
Rheumatoid Arthritis in the European Union
Paris, France and
Tarrytown, N.Y., June 27, 2017 - Sanofi and Regeneron
Pharmaceuticals, Inc. announced today that the European Commission
(EC) has granted marketing authorization for Kevzara®
(sarilumab) in combination with methotrexate (MTX) for the
treatment of moderately to severely active rheumatoid arthritis
(RA) in adult patients who have responded inadequately to - or who
are intolerant to - one or more disease modifying anti-rheumatic
drugs (DMARDs), such as MTX.[1] Kevzara may
be used as monotherapy in case of intolerance to MTX or when
treatment with methotrexate is inappropriate.1
Kevzara is a human monoclonal
antibody that binds to the interleukin-6 receptor (IL-6R) and
blocks pro-inflammatory IL-6 mediated signaling. Elevated levels of
IL-6 are found in the synovial fluid of patients with RA and play
an important role in both the pathologic inflammation and joint
destruction which are hallmarks of RA.1
"RA is a
difficult-to-treat, lifelong disease and many healthcare providers
are challenged with finding a treatment that works for their
patients," said Elias Zerhouni, M.D., President, Global
R&D, Sanofi. "Kevzara works differently than
some of the other most commonly used biologics, and its approval is
good news for the many patients with a high unmet need."
RA affects approximately 2.9
million people in Europe alone.[2] In RA, the
immune system attacks the tissues of the joints, causing
inflammation, joint pain, swelling, stiffness, fatigue, and
eventually joint damage and disability.[3],[4] RA is most
common in those aged 35-50 years old.[5]
"We are pleased
to bring Kevzara to European patients who may not be responding to
the most commonly used biologics such as TNF inhibitors, or who may
be seeking an effective monotherapy to reach their treatment
goals," said George D. Yancopoulos, M.D., Ph.D., Founding
Scientist, President, and Chief Scientific Officer, Regeneron.
"This approval was made possible through the hard
work of our innovative scientists, as well as thousands of
dedicated investigators and patients around the world who
participated in the SARIL-RA clinical trial program."
The EC approval is based upon
receipt of a positive opinion by European Medicine Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP), which
evaluated results from seven Phase 3 trials in the global SARIL-RA
clinical development program. These studies incorporate data from
more than 3,300 adults with moderately to severely active RA who
have had an inadequate response or intolerance to one or more
biologic or non-biologic DMARDs.1
The program includes the Phase 3
MONARCH study, in which treatment with Kevzara 200 mg monotherapy
was superior to adalimumab 40 mg (marketed by AbbVie as
HUMIRA®) monotherapy
in reducing disease activity and improving physical function, with
more patients achieving clinical remission over 24
weeks.1
- At 24 weeks, patients treated
with Kevzara demonstrated greater reduction in disease activity as
measured by change from baseline in the Disease Activity Score with
28 joint count and erythrocyte sedimentation rate (DAS28-ESR), the
primary endpoint of the study (Kevzara, -3.28; adalimumab,
-2.20)
- At 24 weeks, patients treated
with Kevzara demonstrated greater improvement from baseline in
physical function as measured by the Health Assessment
Questionnaire - Disability Index (HAQ-DI), a secondary endpoint of
the study (Kevzara, -0.61; adalimumab, -0.43)
- At 24 weeks, patients treated
with Kevzara achieved higher rates of DAS28-ESR remission
(score<2.6), a secondary endpoint of the study (Kevzara, 26.6%;
adalimumab, 7.0%)
- At 24 weeks, patients treated
with Kevzara demonstrated a greater improvement in signs and
symptoms of RA as measured by the proportion of patients achieving
a 20 percent improvement in the ACR criteria (ACR20) (Kevzara,
71.7%; adalimumab, 58.4%; p=0.0074). The proportion of patients
achieving ACR50 was also higher with Kevzara (Kevzara, 45.7%;
adalimumab, 29.7%; p=0.0017) as well as for ACR70 (Kevzara, 23.4%;
adalimumab, 11.9%; p=0.0036). ACR20, ACR50, and ACR70 response at
week 24 were secondary endpoints of the study.
In the Phase 3 MOBILITY study,
treatment with Kevzara plus MTX reduced signs and symptoms,
improved physical function, and at week 52, inhibited the
progression of structural damage by 91 percent for the Kevzara 200
mg dose and 68 percent for the Kevzara 150 mg dose, compared to
placebo plus MTX. In the Phase 3 TARGET study, treatment with
Kevzara plus DMARD reduced signs and symptoms and improved physical
function, compared to placebo plus DMARD. Detailed results from the
MOBILITY and TARGET studies are available in the Kevzara
(sarilumab) FDA approval press release here.
The recommended dose of Kevzara is
200 mg once every 2 weeks administered as a subcutaneous injection
with a prefilled syringe or prefilled pen.1 Reduction of
dose from 200 mg once every 2 weeks to 150 mg once every 2 weeks is
recommended to help manage certain laboratory abnormalities
(neutropenia, thrombocytopenia, and liver enzyme
elevations).1
The most frequent adverse
reactions observed with Kevzara in clinical studies were
neutropenia, increased alanine aminotransferase, injection site
erythema, upper respiratory infections, and urinary tract
infections. The most common serious adverse reactions were
infections. Treatment with Kevzara should be withheld in patients
who develop a serious infection until the infection is controlled.
Initiating treatment with Kevzara is not recommended in patients
with a low neutrophil count, i.e., absolute neutrophil count (ANC)
< 2 x 109/L and in
patients with a platelet count below 150 x 103/Mu L.
Kevzara is also approved in the
United States and Canada. The companies are also seeking approvals
in a number of other countries globally.
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 biotechnology company that
invents life-transforming medicines for people with serious
diseases. Founded and led by physician-scientists for nearly 30
years, our unique ability to repeatedly and consistently translate
science into medicine has led to six FDA-approved treatments and
over a dozen product candidates, all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye disease, heart disease, allergic and inflammatory
diseases, pain, cancer, and infectious and rare diseases.
Regeneron is accelerating and
improving the traditional drug development process through its
unique VelociSuite® technologies,
including VelocImmune® which yields
optimized fully-human antibodies, and ambitious initiatives such as
the Regeneron Genetics Center, 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.
Sanofi Forward-Looking Statements
This press release contains forward-looking
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Media
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statements that involve risks and uncertainties relating to future
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possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation
Kevzara® (sarilumab)
for the treatment of moderately to severely active rheumatoid
arthritis in adult patients who have responded inadequately to, or
who are intolerant to, one or more disease modifying anti-rheumatic
drugs or other potential indications; the likelihood and timing of
possible regulatory approval and commercial launch of Regeneron's
late-stage product candidates, such as the possible regulatory
approval and commercial launch of Kevzara in additional
jurisdictions; unforeseen safety issues resulting from the
administration of products and product candidates in patients,
including serious complications or side effects in connection with
the use of Regeneron's product candidates in clinical trials, such
as Kevzara; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron's
ability to continue to develop or commercialize Regeneron's
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regulatory obligations and oversight impacting Regeneron's marketed
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business, including those relating to patient privacy; competing
drugs and product candidates that may be superior 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
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commercial success of Regeneron's products and product candidates,
including without limitation Kevzara; coverage and reimbursement
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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 relating to Praluent®
(alirocumab) Injection, the permanent injunction granted by the
United States District Court for the District of Delaware that, if
upheld on appeal, would prohibit Regeneron and Sanofi from
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injunction, the ultimate outcome of such litigation, and the impact
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Contacts Sanofi:
Media Relations
Ashleigh Koss
Tel: +1 908 981 8745
ashleigh.koss@sanofi.com
Global Communications
Sarah Connors Tel: +1 617
252 7639
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sarah.connors@sanofi.com |
Investor Relations George Grofik
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Contacts
Regeneron:
Media Relations
Arleen Goldenberg Tel: 1 (914)
847-3456
Mobile: +1 (914) 260-8788
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Manisha Narasimhan, Ph.D. Tel: 1 (914)
847-5126
Manisha.narasimhan@regeneron.com
|
[1] Kevzara
Summary of Product Characteristics April 2017
[2] National
Rheumatoid Arthritis Foundation. "European Fit to Work report."
Available at http://www.nras.org.uk/european-fit-for-work-report.
Last accessed June 2017
[3] Mayo
Clinic. "Rheumatoid Arthritis." Available at
http://www.mayoclinic.org/diseases-conditions/rheumatoid-arthritis/home/ovc-20197388.
Last accessed June 2017.
[4] Arthritis
Research UK. "What are the symptoms of rheumatoid arthritis?"
Available at:
http://www.arthritisresearchuk.org/arthritis-information/conditions/rheumatoid-arthritis/symptoms.aspx
Last accessed: June 2017
[5] Burton, W,
Morrison, A, Maclean, R, and Ruderman, E. "Systematic review of
studies of productivity loss due to rheumatoid arthritis."
Occupational Medicine 2006;56:18-27
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