NICE recommends Jyseleca® ▼(filgotinib) on NHS in landmark decision for rheumatoid arthritis
NOT FOR DISTRIBUTION IN THE UNITED KINGDOM
- 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
Mechelen, Belgium, 21 January 2021, 08:05 CET – Galapagos NV (Euronext & Nasdaq: GLPG) today welcomed the news that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of the daily oral pill, JYSELECA®▼ (filgotinib) on the National Health Service (NHS) in England for the treatment of eligible adult patients with moderate to severe active rheumatoid arthritis (RA).1 It is the first time in the UK that an advanced therapy has been recommended in people with moderate RA, offering thousands more the potential to achieve remission earlier - potentially slowing the irreversible damage and life-limiting symptoms RA can cause.2 RA is a degenerative auto-immune disease that can cause life-threatening complications.4 The sooner treatment begins, the better the chance of slowing disease progression.2 With thousands of people potentially eligible, the recommendation could help improve many lives as well as lessen the significant societal burden RA has in England.5,6
“We are delighted with the NICE recommendation for Jyseleca today. For patients with moderate to severe RA in England this decision represents a significant new opportunity and especially for those with moderate symptoms who can now receive an advanced treatment earlier,” said Onno van de Stolpe, Galapagos CEO.
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 UK live with RA (around 380,000 in England), and it is recognised as a condition that can cause debilitating physical pain, affect mental health and require chronic care.2 Studies have shown that RA shortens life expectancy, with some estimates putting this at around 10 years.8 Nearly 50% of patients diagnosed with RA suffer from mental health issues with 1 in 6 people having a major depressive disorder.6,9 RA is also a significant burden on the UK economy. Around a third of people diagnosed with RA stop work within two years of diagnosis10 and the combined cost of workdays lost due to osteoarthritis and RA in the UK was estimated at £2.58 billion in 2017 – estimated to rise to £3.43 billion by 2030.5
NICE guidance covers England. Wales and Northern Ireland are expected to follow the guidance with timelines for implementation currently under consideration. Filgotinib will be reviewed separately by the Scottish Medicines Consortium for use on the NHS in Scotland.
Under a new arrangement between Gilead and Galapagos, announced in December 2020, Galapagos will assume sole responsibility for filgotinib in Europe, including the UK. Through a phased transition the majority of activities supporting filgotinib in Europe are expected to be assumed by Galapagos by the end of 2021.
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.
Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in late-stage development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines. More information at www.glpg.com.
Except for filgotinib's approval for the treatment of RA by the European Commission and Japanese Ministry of Health, Labour and Welfare, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority and they are not yet approved for any use outside of clinical trials.
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 31 December 2019 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.
Jyseleca®, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.
VP Investor Relations
+1 781 460 1784
Sofie Van Gijsel
Senior Director Investor Relations
+32 485 19 14 15
Global Head of Communications & Public Affairs
+32 473 824 874
Senior Communications Director
+44 (0) 7717 801900
▼ 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
1 National Institute for Health and Care Excellence. Filgotinib for treating moderate to severe rheumatoid arthritis ID1632. Available at: https://www.nice.org.uk/guidance/proposed/gid-ta10541. Accessed: January 2021
2 National Rheumatoid Arthritis Society. What is RA? Available at https://www.nras.org.uk/what-is-ra-article Accessed: January 2021
3 Data on file. Gilead Science Ltd. UK-INF-2020-09-0025
4 NHS. (2019). Rheumatoid Arthritis. Available: https://www.nhs.uk/conditions/rheumatoid-arthritis/ Accessed January 2021.
5 Versus Arthritis, 2019. The State of Musculoskeletal Health 2019. Available at:
https://www.versusarthritis.org/media/14594/state-of-musculoskeletal-health-2019.pdf Accessed: January 2021
6 Versus Arthritis. Versus Arthritis representation to the Budget 2018. September 2018. Key fact available at
https://www.versusarthritis.org/media/1996/versus-arthritis-response-budget-2018pdf.pdf Accessed: January 2021
7 Filgotinib summary of product characteristics. Available at Jyseleca, INN-filgotinib (europa.eu) Accessed January 2021.
8 NRAS – How Is life expectancy affected by RA? Available at NRAS - National Rheumatoid Arthritis Society Accessed: January 2021
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 January 2021.
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 January 2021.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Synchronoss Announces Appointment of Jeff Miller as Permanent CEO and President8.3.2021 15:21:20 CET | Press release
BRIDGEWATER, N.J., March 08, 2021 (GLOBE NEWSWIRE) -- Synchronoss Technologies, Inc. (NASDAQ: SNCR), a global leader and innovator of cloud, messaging and digital solutions, today announced that its Board of Directors has confirmed Jeff Miller as its President and Chief Executive Officer. Miller had been serving as interim President and CEO of Synchronoss since September 2020 and joined Synchronoss in 2018 as Chief Commercial Officer. Prior to coming to Synchronoss, Miller was President of the Technology Group for IDEAL Industries, a firm focused on designing and delivering solutions for smart commercial buildings and spaces. He also served 16 years with Motorola, most recently as Corporate Vice President and General Manager of Operations in North America for Motorola Mobility, LLC, a division of Lenovo. Miller also held various leadership positions in sales management, marketing, and product management at AT&T during an 11-year tenure. “I have had the opportunity to work closely with
AMG Advanced Metallurgical Group N.V. Announces Long-Term Spent Catalyst Recycling Agreement8.3.2021 15:00:00 CET | Press release
Amsterdam, 8 March 2021 --- AMG Advanced Metallurgical Group N.V. ("AMG", EURONEXT AMSTERDAM: "AMG") is pleased to announce that AMG Vanadium has signed a new long-term, multi-year agreement to process and recycle spent catalysts from a major oil refinery operator in North America. Located in Cambridge, Ohio, AMG Vanadium specializes in the environmentally beneficial conversion of oil refinery and power plant waste products into specialty metals used by global steel producers in automotive, energy transmission and infrastructure applications. By using materials that would otherwise be discarded as waste, AMG Vanadium facilitates environmental stewardship, energy conservation and resource recovery. About AMG AMG is a global critical materials company at the forefront of CO2 reduction trends. AMG produces highly engineered specialty metals and mineral products and provides related vacuum furnace systems and services to the transportation, infrastructure, energy, and specialty metals & ch
Nexstim Abp offentliggör EU-tillväxtprospekt avseende en företrädesemission på 6,6 miljoner euro8.3.2021 14:15:00 CET | Pressemelding
Företagsmeddelande, insiderinformation, Helsingfors den 8 mars 2021 kl. 15.15 (EET) Nexstim Abp offentliggör EU-tillväxtprospekt avseende en företrädesemission på 6,6 miljoner euro Nexstim Abp (NXTMH:HEX, NXTMS:STO) (”Nexstim” eller ”bolag”) meddelar med hänvisning till bolagets företagsmeddelande utgiven tidigare i dag, om en företrädesemission av cirka 6,6 miljoner euro att bolaget har upprättat ett EU-tillväxtprospekt som Finansinspektionen godkände den 8 mars 2021. Bolagets styrelse beslutade att offentliggöra EU-tillväxt prospektet den 8 mars 2021 och det ska notifieras till Sverige. EU-tillväxtprospektet på finska läggs omkring den 8 mars 2021 ut på Nexstims webbplats på www.nexstim.com/investors/rights-issue-2021 och tillhandahålls också på bolagets registrerade adress på Elimäkigatan 9 B, 00510 Helsingfors. Dessutom görs EU-tillväxtprospektet på finska tillgängligt på receptionen på Nasdaq Helsinki på Fabiansgatan 14, 00100 Helsingfors. EU-tillväxtprospektet på engelska och en
Nexstim Plc publishes an EU growth prospectus regarding EUR 6.6 million subscription rights issue8.3.2021 14:15:00 CET | Press release
Company announcement, inside information, Helsinki, 8 March 2021 at 3.15 PM (EET) Nexstim Plc publishes an EU growth prospectus regarding EUR 6.6 million subscription rights issue Nexstim Plc (NXTMH:HEX, NXTMS:STO) (”Nexstim” or ”Company”) announces with reference to the company announcement published earlier today regarding a subscription rights issue totaling approximately EUR 6.6 million , that the Company has prepared an EU growth prospectus which the Finnish Financial Supervisory Authority (FIN-FSA) has approved on 8 March 2021. The Board of Directors of Nexstim has resolved to publish the EU growth prospectus on 8 March 2021 and it shall be notified to Sweden. Finnish version of the EU growth Prospectus will be available approximately on 8 March 2021 on the Nexstim’s website at http://www.nexstim.com/investors/rights-issue-2021 and at the registered office of the Company at Elimäenkatu 9 B, 00510 Helsinki. Moreover, the Finnish version of the EU growth prospectus will be availabl
Saniona får återkoppling från FDA gällande den regulatoriska vägen framåt för Tesomet mot hypotalamisk fetma8.3.2021 14:00:00 CET | Pressemelding
PRESSMEDDELANDE 8 mars 2021 Saniona (OMX: SANION), ett biofarmaceutiskt företag med klinisk utveckling fokuserad på sällsynta sjukdomar, meddelar idag att det amerikanska läkemedelsverket FDA lämnat återkoppling som ytterligare klarlägger det regulatoriska spåret för Tesomet som behandling av hypotalamisk fetma (HO). Baserat på den erhållna återkopplingen går Saniona vidare med planerna att inleda en fas 2b-studie på HO under första halvåret innevarande år. ”I dagsläget finns inga godkända mediciner för hypotalamisk fetma, en sällsynt sjukdom sekundär till skador i hypotalamus. Sjukdomen kännetecknas av svårhanterlig viktuppgång och kompliceras av okontrollerbar hunger”, säger Rudolf Baumgartner, Sanionas Chief Medical Officer och Head of Clinical Development. ”Återkopplingen från FDA är uppmuntrande, och vi ser fram emot att fortsätta den konstruktiva dialogen med myndigheten medan vi förbereder starten av vår kliniska fas 2b-studie med Tesomet.” Som Saniona tidigare meddelat har FDA
Saniona Receives Feedback from U.S. FDA Providing a Regulatory Path Forward for Tesomet in Hypothalamic Obesity8.3.2021 14:00:00 CET | Press release
PRESS RELEASE March 8, 2021 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, today announced it received feedback from the U.S. Food and Drug Administration (FDA) providing further clarity on a regulatory path for Tesomet in the treatment of hypothalamic obesity (HO). Based on this feedback, Saniona is proceeding with plans to initiate a Phase 2b study in HO in the first half of this year. “There is currently no medicine approved for hypothalamic obesity, a rare disease secondary to hypothalamic injury, characterized by intractable weight gain and complicated by uncontrollable hunger,” said Rudolf Baumgartner, M.D., Chief Medical Officer and Head of Clinical Development at Saniona. “We are encouraged by this feedback from the FDA and look forward to continuing a constructive dialogue with them as we prepare to initiate our Phase 2b clinical trial with Tesomet.” Saniona previously announced that the FDA had highlighted the potential for off-lab
Signify share repurchase periodic update8.3.2021 13:00:00 CET | Press release
Press Release March 8, 2021 Signify share repurchase periodic update Eindhoven, the Netherlands –Signify (Euronext: LIGHT), the world leader in lighting, today announced that it has repurchased 160,815 shares in the period March 1 to March 5, 2021. The shares were repurchased at an average price of EUR 36,64 per share and an aggregate amount of EUR 5.9 million. These repurchases were made as part of the company’s repurchase program, which was announced on February 25, 2021. Signify will use the shares to cover obligations arising from its long-term incentive performance share plan and other employee share plans. The total number of shares repurchased under this program to date is 216,690 shares for a total consideration of EUR 7.9 million. Details on the share buyback transactions can be found here. --- END --- For further information, please contact: Signify Investor Relations Thelke Gerdes Tel: +31 6 1801 7131 E-mail: firstname.lastname@example.org Signify Corporate Communications Elco va