JYSELECA®▼(filgotinib) receives authorisation as treatment for rheumatoid arthritis

JYSELECA has received authorisation from the European Commission (EC) for treatment of rheumatoid arthritis

It has been announced that JYSELECA®▼(filgotinib), an oral JAK inhibitor, has received marketing authorisation from the European Commission (EC) for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease‑modifying anti‑rheumatic drugs (DMARDs). JYSELECA may be used as monotherapy or in combination with methotrexate (MTX).[i] The decision from the EC means that there is now a new treatment option for these patients that has demonstrated durable efficacy combined with a consistent safety profile through 52 weeks.1

More than 400,000 people in the UK[ii] and 45,000 people in Ireland[iii] live with RA, a condition that can cause debilitating physical pain, affect mental health and require chronic care.2 Around 70 percent of those affected in the UK are estimated to have moderate to severe disease.[iv] However, fewer than one in five people with RA currently achieve disease remission, highlighting the need for continued research and novel therapeutic options in this area.[v]

Filgotinib’s marketing authorisation is supported by data from over 3500 patients treated with filgotinib across the Phase 3 FINCH and Phase 2 DARWIN programs.1,[vi],[vii] All three FINCH trials met their primary endpoints, and filgotinib consistently achieved relevant treatment targets and showed the ability to inhibit the progression of structural joint damage compared with placebo.1 Across the FINCH and DARWIN trials, once-daily filgotinib demonstrated a consistent clinical safety profile when administered as monotherapy or in combination with methotrexate.1 Common side effects of filgotinib include upper respiratory tract infection, urinary tract infection, dizziness and nausea.1

Paul Emery, OBE, Versus Arthritis Professor, Director of Leeds NIHR BRC, Leeds Institute of Rheumatic and MSK Medicine, Leeds University said: “Today is another key milestone in the fight against rheumatoid arthritis. This is a widespread condition that can be incapacitating for many of those affected, yet controlling RA and the damage it can cause remains a real challenge. The arrival of filgotinib is welcome news as it represents a new option that directly targets an underlying cause of this condition and offers us another way to inhibit the damage RA can cause.”

Clare Jacklin, CEO of the National Rheumatoid Arthritis Society (NRAS): “Unbelievably, it is still common for people to mistake rheumatoid arthritis as just wear and tear or ‘part of getting old’ and this leads to deep misunderstanding and an underestimation of the reality of this debilitating painful condition. RA is a problem that occurs when the body’s own immune system starts to attack the healthy lining in between the joints. RA affects in excess of 400,000 people – young and old – across the UK, with symptoms including pain, joint swelling and stiffness as well as chronic fatigue that can all lead to potential mental health issues and financial hardship. New options that can help alleviate symptoms are sorely needed and we therefore welcome today’s news as another important step forward for lessening the burden of RA on the individual, their families, the health service and the economy.”

References

[i] Filgotinib Summary of Product Characteristics. September 2020.

[ii] National Rheumatoid Arthritis Society. What is RA? Available at https://www.nras.org.uk/what-is-ra-article Accessed September 2020

[iii] Arthritis Ireland – Experiences of living with RA. Key fact available at https://www.arthritisireland.ie/news/experiences-of-living-with-rheumatoid-arthritis-collected-in-new-book Accessed September 2020

[iv] Data on file. Gilead Science Ltd. UK-INF-2020-09-0025.

[v] Ajeganova S and Huizinga T. Sustained remission in rheumatoid arthritis: latest evidence and clinical considerations. Ther Adv Musculoskel Dis. 2017;9:249- 262. Key fact available at www.doi.org/10.1177/1759720X17720366 Accessed September 2020

[vi] Kavanaugh A, Kremer J, Ponce L, et al. Filgotinib (GLPG0634/GS-6034), an oral selective JAK1 inhibitor, is effective as monotherapy in patients with active rheumatoid arthritis: results from a randomised, dose-finding study (DARWIN 2). Ann Rheum Dis. 2017;76:1009-1019.

[vii] Westhovens R, Taylor PC, Alten R, et al. Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dose-finding study (DARWIN 1). Ann Rheum Dis. 2017;76:998-1008.