Sanofi Announces Approval of Kevzara® (sarilumab) to Treat Adult Patients with Moderately to Severely Active Rheumatoid Arthritis (RA) in the European Union

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 

1. Sanofi data on file, June 2017
2. World Health Organization. "Chronic rheumatic condition." Available at: http://www.who.int/chp/topics/rheumatic/en/ (Accessed June 2017).
3. 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).
4. NRAS, European Fit for Work report. Available at: http://www.nras.org.uk/european-fit-for-work-report (Accessed June 2017).
5. Rheumatoid Arthritis 'What is rheumatoid arthritis?' Available at: https://www.rheumatoidarthritis.org/ra/ (Accessed June 2017).
6. 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).
7. 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).
8. 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).
9. 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).
10. 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).
11. 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).
12. 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).
13. 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).
14. British Society of Immunology. Rheumatoid Arthritis. Available at: https://www.immunology.org/public-information/bitesized-immunology/immune-dysfunction/rheumatoid-arthritis  (Accessed June 2017). 
15. 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).
16. 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).
17. 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
18. 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).
19. 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