DUBLIN, June 27, 2017 /PRNewswire/ --
- Marketing
authorisation for sarilumab offers a
new treatment option for people in Ireland living with the
debilitating effects of RA -
Sanofi and its specialty care global business unit, Sanofi
Genzyme, announced today that the European Commission (EC) has
granted marketing authorisation 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).[1] Sarilumab may be used
as monotherapy in case of intolerance to MTX or when treatment with
methotrexate is
inappropriate.[1]
"Patients with RA can suffer a combination of
debilitating symptoms which often make it difficult to perform
simple daily activities", said Dr
Sinead Harney, Consultant
Rheumatologist, Cork University Hospital. "New treatment
options are an important part of managing this problem and help
ease the burden on patients."
"RA is a chronic and debilitating lifelong disease
which affects about 45,000 people in Ireland. Despite a number of existing
treatments, there are still patients in need of an effective
alternative. Sarilumab presents an additional option for those
people," commented Mary
Dickens, Country Chair & General Manager of General
Medicines of Sanofi Ireland.
RA is one of the most common rheumatic conditions, affecting
approximately 45,000 people living in Ireland and approximately 2.9 million people
in Europe.[2],[3],[4]
People with RA can suffer from severe pain, swelling, stiffness, or
fatigue as the immune system attacks the tissues of the joints,
causing inflammation and destroying bone and
cartilage.[5] The impact these
symptoms and complications have on daily life is often
underestimated.
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).[6] The
committee evaluated results from seven Phase 3 trials in the global
SARIL-RA clinical development programme of 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.[6]-[13]
Sarilumab was developed jointly by Sanofi and Regeneron. Full
summary of product characteristics can be accessed at
http://www.medicines.ie
About Rheumatoid Arthritis (RA)
RA is a chronic systemic autoimmune disease that can affect
people of any age but is most common in people aged between 30-50
years[14] with 75% of
patients diagnosed while of working
age.[15] Up to two in
five people with inadequately treated rheumatoid arthritis will
have stopped working within five years of being
diagnosed.[4] RA occurs more often
in women than in men (75% vs 25%) and can be seriously
debilitating, preventing people from completing everyday activities
like washing their hair and cooking a
meal.[16] People with RA are at an
increased risk of cardiovascular disease, infections and certain
cancers.[17] In
addition, as many as 40% of people with RA may experience
significant symptoms of
depression.[18]
About Kevzara®
(sarilumab)
Sarilumab is a human monoclonal antibody that binds to the
interleukin-6 receptor (IL-6R), and has been shown to block
pro-inflammatory IL-6 mediated
signalling.[19] IL-6 is
a protein in the body that, in excess and over time, can contribute
to both the pathological inflammation and joint destruction that
are associated with
RA.[19]
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs.
Sanofi is organised 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.
References
- Sanofi data on file, June
2017
- World Health Organization. "Chronic rheumatic condition."
Available at: http://www.who.int/chp/topics/rheumatic/en/ (Accessed
June 2017).
- Arthritis Ireland 'Living with
Rheumatoid Arthritis'. Available at:
http://www.arthritisireland.ie/assets/63/91963363-BDAD-4A43-908F6A22D98162C8_document/RA_BOOKLET_REV10_Web.pdf
(Accessed June 2017).
- NRAS, European Fit for Work report. Available at:
http://www.nras.org.uk/european-fit-for-work-report (Accessed
June 2017).
- Rheumatoid Arthritis 'What is rheumatoid arthritis?' Available
at: https://www.rheumatoidarthritis.org/ra/ (Accessed June 2017).
- European Medicines Agency Committee for Medicinal Products for
Human Use (CHMP). Summary of opinion (initial authorisation) for
Kevzara / sarilumab. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004254/WC500226186.pdf.
(Accessed June 2017).
- Sanofi. Efficacy and Safety of Sarilumab and Adalimumab
Monotherapy in Patients With Rheumatoid Arthritis
(SARIL-RA-MONARCH). Available at:
https://clinicaltrials.gov/ct2/show/NCT02332590 NLM Identifier:
NCT02332590.(Accessed June
2017).
- Sanofi. Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in
Rheumatoid Arthritis Patients (RA-MOBILITY). Available at:
https://clinicaltrials.gov/show/NCT01061736 NLM Identifier:
NCT01061736. (Accessed June
2017).
- Sanofi. To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In
Patients With RA Who Are Not Responding To Or Intolerant Of
Anti-TNF Therapy (SARIL-RA-TARGET). Available at: NLM Identifier:
https://clinicaltrials.gov/ct2/show/NCT01709578 NLM Identifier:
NCT01709578. (Accessed June
2017).
- Sanofi. To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In
Patients With Rheumatoid Arthritis (SARIL-RA-EASY). Available
at: https://clinicaltrials.gov/ct2/show/NCT02057250 NLM
Identifier: NCT02057250. (Accessed June
2017).
- Sanofi. To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other
RA Drugs in Patients With RA Who Are Not Responding to or
Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN). Available at:
https://clinicaltrials.gov/show/NCT01768572 NLM Identifier:
NCT01768572. (Accessed June
2017).
- Sanofi. Long Term Evaluation of Sarilumab in Rheumatoid
Arthritis Patients (RA-EXTEND). Available at:
https://clinicaltrials.gov/show/NCT01146652 NLM Identifier:
NCT01146652. (Accessed June
2017).
- Sanofi. To Evaluate the Immunogenicity and Safety of Sarilumab
Administered as Monotherapy in Patients With Rheumatoid Arthritis
(RA) (SARIL-RA-ONE). Available at:
https://clinicaltrials.gov/ct2/show/NCT02121210 NLM Identifier:
NCT02121210. (Accessed June
2017).
- British Society of Immunology. Rheumatoid Arthritis. Available
at:
https://www.immunology.org/public-information/bitesized-immunology/immune-dysfunction/rheumatoid-arthritis
(Accessed June 2017).
- NRAS. Right answer? Key questions for my new MP. Available at:
http://www.nras.org.uk/data/files/Get%20Involved/Campaign/Right%20Answer%20download%20booklet.pdf.
(Accessed June 2017).
- The British Society for Rheumatology. Simple Tasks: Fast Facts.
http://80.87.12.43/patient_information/simple_tasks/did_you_know.aspx.
(Accessed June 2017).
- Dougados M, Soubrier M, Antunez A, et al Prevalence of
comorbidities in rheumatoid arthritis and evaluation of their
monitoring: results of an international, cross-sectional study
(COMORA) Annals of the Rheumatic Diseases Published Online First:
04 October 2013. doi:
10.1136/annrheumdis-2013-204223
- Arthritis Foundation. 'Rheumatoid Arthritis and Depression'
Available at:
http://www.arthritis.org/living-with-arthritis/comorbidities/depression-and-arthritis/depression-rheumatoid-arthritis.php
. (Accessed June 2017).
- Burmester GR, Lin Y, Patel R, et al. Ann Rheum Dis. Published
Online First: 17 November 2016.
doi:10.1136/annrheumdis-2016-210310
Contacts:
Media Relations
Stefanie Holman
Sanofi UK & Ireland
Tel.: 01865 405 200 or 07740 935 273
stefanie.holman@sanofi.com
Anna Duffy
Edelman
Tel.: 01 678 9333 or 086 088 0928
anna.duffy@edelman.com