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SMC advice issued for Sanofi’s Kevzara®(sarilumab) in Rheumatoid Arthritis (RA)

Sanofi
Posted on: 10 Apr 18

SMC advice issued for Sanofi’s Kevzara®(sarilumab) in Rheumatoid Arthritis (RA)[i]

  • The Scottish Medicines Consortium has accepted Kevzara® (sarilumab) for restricted use within NHS Scotland for the treatment of severe RA that has not responded to intensive therapy with a combination of conventional DMARDs1
  • This is in line with other existing biologic therapies[ii],[iii],[iv]
  • RA affects approximately 60,000 people in Scotland[v] and is most commonly diagnosed in people aged 30-50 years[vi]

Guildford, UK – April 9, 2018 The Scottish Medicines Consortium (SMC) issued positive advice on Sanofi’s Kevzara® (sarilumab) for routine use on the National Health Service (NHS) in Scotland, in combination with methotrexate (MTX) for the treatment of adults with severe rheumatoid arthritis (RA) who have not responded adequately to intensive therapy with a combination of conventional Disease-Modifying-Anti-Rheumatic-Drugs (DMARDs).1 This decision gives severe RA patients in Scotland a further option when conventional treatments are not adequately controlling the condition.

“We are delighted to see more treatments becoming available in Scotland for rheumatoid arthritis,” says Gordon Boyd, Medical Director UK & Ireland at Sanofi Genzyme. “This is a progressive disease which needs to be controlled as early as possible to prevent irreversible damage. There are still a large number of people with severe RA for whom DMARDs are not enough. Another treatment option is great news as it brings them closer to potentially getting their disease under control.”

Kevzara® (sarilumab) has also been accepted by the SMC as a monotherapy for severe RA if a patient is either intolerant to, or inappropriate for, treatment with MTX. Additionally, Kevzara® (sarilumab) can be used in combination with MTX when severe disease is inadequately controlled by a TNF agonist and patients are ineligible for treatment with rituximab.1

On 23 June 2017, Kevzara® (sarilumab) was granted EU marketing authorisation in combination with MTX for the treatment of moderately to severely active RA in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs.[vii] Kevzara® (sarilumab) Sarilumab can also be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.7

Human impact of rheumatoid arthritis

There are nearly 60,000 people in Scotland with rheumatoid arthritis5, 75% of whom are diagnosed while of working age 8. RA does not just affect bone and cartilage, and the impact that symptoms of severe pain, swelling, stiffness, or fatigue9 have on daily life is often underestimated. People with the disease are at increased risk of developing one or more additional conditions co-occurring with their RA, such as cardiovascular disease.9 In addition, as many as 40% of people with RA may experience significant symptoms of depression.10 Up to 40% of people with RA will not be able to work five years after diagnosis, and losing a job can be a major cause of depression.11

“At Sanofi, we are continuously striving to help people who are struggling with complex and debilitating diseases,” added Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme. “Finding the right treatment for people with rheumatoid arthritis is crucial. Kevzara has shown its value as a further treatment option for those with severe RA and the SMC’s decision confirms it.”

Previous funding decisions

Last year, Kevzara® (sarilumab) was also recommended by the National Institute for Health and Clinical Excellence (NICE) for routine use on the NHS in England in combination with MTX as a treatment option for adults with severe, active RA whose disease has responded inadequately to intensive therapy with conventional or other DMARDs.12 The NICE final guidance also recommends Kevzara® (sarilumab) for monotherapy in adults with severe, active RA who cannot take MTX due to contraindications or intolerance.12

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.7 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.7 Kevzara® (sarilumab)  is administered via an ‘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 In the MONARCH study, Kevzara® (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 a tumour necrosis factor (TNF) inhibitor.13

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 Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Media Relations Contact

Stefanie Holman

Sanofi UK & Ireland

Tel.: 01865 405 200 or 07740 935 273

stefanie.holman@sanofi.com

 

Tara Breen

Red Consultancy

Tel.: 020 7025 6524 or 07813 252 673

Tara.Breen@redconsultancy.com

 

▼ The black triangle means this medicine is subject to additional monitoring. This will allow quick identification of new safety information. Side effects of medicines should be reported to your doctor or pharmacist.


[i] Scottish Medicines Consortium. Sarilumab (Kevzara). Available at: https://www.scottishmedicines.org.uk/medicines-advice/sarilumab-kevzara-fullsubmission-131418/. (Accessed April 2018).

[ii] Scottish Medicines Consortium. Adalimumab. Available at: https://www.scottishmedicines.org.uk/medicines-advice/adalimumab-humira-fullsubmission-8103/. (Accessed April 2018).

[iii] Scottish Medicines Consortium. Tocilizumab. Available at: https://www.scottishmedicines.org.uk/medicines-advice/tocilizumab-roactemra-resubmission-77412/. (Accessed April 2018).

[iv] Scottish Medicines Consortium. Infliximab. Available at: https://www.scottishmedicines.org.uk/medicines-advice/infliximab-remsima-fullsubmission-100614/. (Accessed April 2018).

[v] National Rheumatoid Arthritis Society. Employment and Rheumatoid Arthritis in Scotland. A national picture. Available at: https://www.nras.org.uk/data/files/Publications/Scottish%20Survey%20Doc%202010.pdf. (Accessed April 2018).

[vi] British Society of Immunology. ‘Rheumatoid Arthritis.’ Available at: https://www.immunology.org/public-information/bitesized-immunology/immune-dysfunction/rheumatoid-arthritis. (Accessed April 2018).

[vii] EMC. Kevzara (sarilumab) summary of product characteristics. Available at: http://www.medicines.org.uk/emc/medicine/33836. (Accessed April 2018).

8 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 April 2018).

9 Rheumatoid Arthritis ‘What is rheumatoid arthritis?’ Available at: https://www.rheumatoidarthritis.org/ra/. (Accessed April 20118).

10 Arthritis Foundation. ‘Rheumatoid Arthritis and Depression’. Available at: http://www.arthritis.org/living-with-arthritis/comorbidities/depression-and-arthritis/depression-rheumatoid-arthritis.php. (Accessed April 2018).

11 Bevan S, Quadrello T, McGee R, et al. ‘Fit For Work? Musculoskeletal Disorders in the European Workforce.’ The Work Foundation, London, 2009. 

12 NICE. Sarilumab for previously treated moderate to severe active rheumatoid arthritis [ID994]. Available at:  https://www.nice.org.uk/guidance/ta485. (Accessed April 2018).

13 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.

 

For more information:
www.scottishmedicines.org.uk/medicines-advice/sarilumab-kevzara-fullsubmission-131418

Editor's Details

Stefanie Holman
Sanofi UK & Ireland
01865 405 200 or 07740 935 273
Tara.Breen@redconsultancy.com

Last updated on: 10/04/2018

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