NOT FOR DISTRIBUTION IN THE
- NICE guidance, for the first time in the
UK , supports access to an advanced therapy for people with moderate as well as severe rheumatoid arthritis (RA) - aiming to avoid irreversible damage as early as possible1 - More than 400,000 people across the
UK live with RA2 and around 70% have moderate or severe disease3
“We are delighted with the NICE recommendation for Jyseleca today. For patients with moderate to severe RA in
Filgotinib is a once daily oral pill that can be given on its own (as a monotherapy) or used alongside another common RA medicine, called methotrexate.7 Eligible patients with moderate or severe RA will have responded inadequately to intensive therapy with 2 or more conventional disease-modifying antirheumatic drugs (DMARDs).1 Eligible patients with severe disease will also have wider access to filgotinib in line with criteria defined by NICE. Filgotinib is an advanced therapy which, in RA, is a term used to describe biologic DMARDs and targeted synthetic DMARDs.1
More than 400,000 people in the
NICE guidance covers
Under a new arrangement between Gilead and Galapagos, announced in
About filgotinib7
Filgotinib is a Janus-kinase (JAK) inhibitor and works by preferentially targeting JAK1, part of a specific pathway involved in inflammation – an immune response of the body that causes symptoms of RA. In clinical studies, filgotinib has been shown to significantly improve the chance of disease remission (a DAS28-CRP score of <2.6, indicating few or no symptoms).7 In the FINCH 1 study of 1,755 patients with RA who had an inadequate response to methotrexate, 34% of patients given filgotinib 200mg + methotrexate (n=475) achieved disease remission after just 12 weeks, compared to 9% of a group given placebo (n=475). After 24 weeks, 48% of patients in this group had achieved remission vs. 16% of those on placebo and these response levels were sustained through 52 weeks. In many cases, responses were seen within two weeks (measured using an ACR20 score).
Data supporting filgotinib include more than 3,800 patients treated across the Phase 3 FINCH and Phase 2 DARWIN programmes. In the FINCH studies, filgotinib consistently achieved ACR20/50/70 criteria, with improvements in all individual ACR components compared with placebo or methotrexate.
Across the FINCH and DARWIN trials, the most common adverse reactions were nausea, upper respiratory tract infection, urinary tract infection and dizziness. Rates of herpes zoster and pneumonia were uncommon. The frequency of serious infections in the filgotinib 200mg group was 1.0 percent compared with 0.6 percent in the placebo group. In an integrated safety analysis in seven clinical trials the rates of major adverse cardiac events (MACE) and venous thromboembolism (VTE) with filgotinib were comparable to placebo. The rates of serious infections remained stable with long-term exposure.
About Galapagos
Except for filgotinib's approval for the treatment of RA by the
Galapagos Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs with filgotinib may not support registration or further development due to safety, efficacy or other reasons, the timing or likelihood of additional regulatory authorities approval of marketing authorization for filgotinib, such additional regulatory authorities requiring additional studies, the timing or likelihood of additional guidance or final appraisal determinations for filgotinib, Galapagos’ reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, the timing of and the risks related to completing and implementing the amendment of our arrangement with Gilead for the commercialization and development of Jyseleca (filgotinib), as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended
Jyseleca®, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.
CONTACTS:
Investors:
Elizabeth Goodwin
VP Investor Relations
+1 781 460 1784
Senior Director Investor Relations
+32 485 19 14 15
ir@glpg.com
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Global Head of Communications & Public Affairs
+32 473 824 874
+44 (0) 7717 801900
mailto:communications@glpg.com
▼ The black triangle next to JYSELECA® means that it is subject to additional monitoring. This is to allow quick identification of new safety information. Patients can help with this by reporting any side effects that they experience. More information can be found online at https://www.mhra.gov.uk/yellowcard
References
1
2
3 Data on file.
4
5 Versus Arthritis, 2019. The State of
https://www.versusarthritis.org/media/14594/state-of-musculoskeletal-health-2019.pdf Accessed:
6 Versus Arthritis. Versus Arthritis representation to the Budget 2018.
https://www.versusarthritis.org/media/1996/versus-arthritis-response-budget-2018pdf.pdf Accessed:
7 Filgotinib summary of product characteristics. Available at Jyseleca, INN-filgotinib (europa.eu) Accessed
8 NRAS – How Is life expectancy affected by RA? Available at NRAS -
9 KCL. (2018). Mental health linked to disease flare of patients with rheumatoid arthritis. Available: https://www.kcl.ac.uk/news/mental-health-linked-to-disease-flare-of-patients-with-rheumatoid-arthritis-3 Accessed
10 NICE. (2018). Rheumatoid arthritis in adults: management. Available: https://www.nice.org.uk/guidance/ng100/resources/rheumatoid-arthritis-in-adults-management-pdf-66141531233989 Accessed
Attachment
- NICE recommends Jyseleca® ▼(filgotinib) on
NHS in landmark decision for rheumatoid arthritis
Source:
2021 GlobeNewswire, Inc., source