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NICE Issues Positive Recommendation for Sanofi’s Rheumatoid Arthritis Treatment Kevzara® (sarilumab) in Final Appraisal Determination

Recommendation paves way for new option for adults with active, severe rheumatoid arthritis who respond inadequately to intensive therapy with conventional or other disease modifying anti-rheumatic drugs (DMARDs)

 

Guildford, UK – 22 September, 2017 - Sanofi and its specialty care global business unit, Sanofi Genzyme, today announced that the National Institute for Health and Care Excellence (NICE) has published its Final Appraisal Determination (FAD) recommending Kevzara® (sarilumab) for routine use on the National Health Service (NHS) in England in combination with methotrexate (MTX) as a treatment option for adults with severe, active rheumatoid arthritis whose disease has responded inadequately to intensive therapy with conventional or other disease modifying anti-rheumatic drugs (DMARDs).1 The FAD also recommends Kevzara® (sarilumab) for monotherapy in adults with severe, active rheumatoid arthritis who are intolerant to MTX .1 These are draft recommendations; Final Guidance for Kevzara® (sarilumab) is expected from NICE later this year.

Over the years, we have made great progress in the diagnosis and management of RA, yet many patients still do not achieve symptom control despite the treatment choices available. NICE’s recommendation of sarilumab is good news for people with RA and their specialists as it potentially adds another treatment option,” said Professor Ernest Choy, Consultant Rheumatologist, University of Cardiff. “Rheumatoid arthritis is an unpredictable chronic disease. It strikes at any age, often during working life. It causes severe pain and comorbidities, which can have a huge impact on all aspects of their daily life including psychological wellbeing.”

More than 400,000 people in the UK live with RA,2 and the impact that symptoms of severe pain, swelling, stiffness, or fatigue3 have on daily life is often underestimated. While RA is typically thought of as a disease of the joints, its impact extends beyond bones and cartilage. People with the disease are at an increased risk of cardiovascular disease, infections and certain cancers.4 In addition, as many as 40% of people with RA may experience significant symptoms of depression.5

“This recommendation brings us one step closer to making Kevzaraavailable to adult patients with severe RA and reinforces Sanofi’s ongoing commitment to helping people impacted by often complex, misunderstood and debilitating diseases,” added Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme.

About Kevzara® (sarilumab)

Kevzara® (sarilumab) is a fully human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to block pro-inflammatory IL-6 mediated signalling.6 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.6Kevzara® (sarilumab) is administered in two clicks via an innovative ‘auto-injector’ device (that was co-created with RA patients), or by using a pre-filled syringe.

The efficacy and safety of Kevzara® (sarilumab) were assessed in three randomised, double-blind, controlled multicentre studies (MOBILITY and TARGET were placebo-controlled studies and MONARCH was an active comparator-controlled study) in adult patients with moderately to severely active rheumatoid arthritis.7 Sarilumab demonstrated clinically meaningful improvements in adult patients with moderately to severely active RA, reducing signs and symptoms experienced by people with RA and improving physical function compared with another biological therapy.8

Kevzara® (sarilumab) was granted EU marketing authorisation 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) on 23 June, 2017. The licence also permits use as monotherapy in patients who are intolerant of MTX or for whom treatment with MTX is inappropriate.7

Kevzara® (sarilumab) was developed jointly by Sanofi and Regeneron. Full summary of product characteristics can be accessed at http://www.medicines.org.uk/emc/medicine/33836 .

About Rheumatoid Arthritis (RA)

Rheumatoid arthritis (RA) is both progressive and chronic, and is caused by a malfunction of the immune system. 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.3 The impact that these symptoms and complications have on daily life is often underestimated.

RA can affect people of any age, but is most common in people aged between 30-50 years9 with 75% of patients diagnosed while of working age.10 Up to two in five people with inadequately treated RA will have stopped working within five years of being diagnosed.11

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

  • NICE. Sarilumab for previously treated moderate to severe active rheumatoid arthritis [ID994]. Available at: https://www.nice.org.uk/guidance/gid-ta10161/documents/final-appraisal-determination-document (Accessed September 2017).
  • Arthritis Research UK. ‘State of musculoskeletal health 2017.’ Available at: http://www.arthritisresearchuk.org/research/news-for-researchers/2017/june/state-of-musculoskeletal-health-2017.aspx. (Accessed September 2017).
  • Rheumatoid Arthritis ‘What is rheumatoid arthritis?’ Available at: https://www.rheumatoidarthritis.org/ra/. (Accessed September 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). Ann Rheum Dis. 2014 Jan;73(1):62-8.
  • Arthritis Foundation. ‘Rheumatoid Arthritis and Depression’. Available at: http://www.arthritis.org/living-with-arthritis/comorbidities/depression-and-arthritis/depression-rheumatoid-arthritis.php. (Accessed September 2017).
  • Pharmaceuticals Community Register.  Community register of medicinal products for human use: Kevzara. European Commission. June 27 2017. Available at:  http://ec.europa.eu/health/documents/community-register/html/h1196.htm (Accessed September 2017).
  • Kevzara (sarilumab) summary of product characteristics. Available at: http://www.medicines.org.uk/emc/medicine/33836. (Accessed September 2017).
  • Burmester GR, Lin Y, Patel R, et al. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis. 2017 May;76(5):840-847.
  • British Society of Immunology. ‘Rheumatoid Arthritis.’ Available at: https://www.immunology.org/public-information/bitesized-immunology/immune-dysfunction/rheumatoid-arthritis.  (Accessed September 2017).
  • National Rheumatoid Arthritis Society. ‘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 September 2017).
  • Bevan S, Quadrello T, McGee R, et al. ‘Fit For Work? Musculoskeletal Disorders in the European Workforce.’ The Work Foundation, London, 2009.

Date of preparation: September 2017: Job bag number: SAGB.SARI.17.09.1114

Updated: September 22, 2017

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