2020. https://www.ema.europa.eu/. medwireNews: The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the Janus kinase (JAK)1 -selective inhibitor filgotinib for the treatment of rheumatoid arthritis (RA). What does this signal for Galapagos, Gilead, and other biotechs working in inflammatory disease? 28th September 2020. by. The JAK-STAT pathway: impact on human disease and therapeutic intervention. Galapagos and Gilead complete closing of their global collaboration for filgotinib [media release]. There were no clinically relevant differences in exposures when filgotinib was administered with a high-fat or low-fat meal compared with the fasted state; therefore, filgotinib can be administered with or without food. Ann Rheum Dis. 2018;392(10162):2378–87. Impact of Different JAK Inhibitors and Methotrexate on Lymphocyte Proliferation and DNA Damage. Galien R, Vayssiere B, De Vos S, et al. Combe B, Kivitz A, Tanaka Y, et al. Caution is required when filgotinib is coadministered with CYP1A2, P-gp or BRCP substrates that have a narrow therapeutic index. Filgotinib therapy was associated with a small, transient increase in mean absolute lymphocyte count that remained within normal reference ranges and gradually returned to, or close to, baseline levels over 12 weeks’ treatment. -, O'Shea JJ, Schwartz DM, Villarino AV, et al. Oral filgotinib is absorbed rapidly, with the median peak plasma concentration (Cmax) of filgotinib reached 2–3 h post dose and that of its main metabolite GS-829845 reached 5 h post dose following multiple dosing [3]. 2018 Dec 1;392(10162):2367-2377. doi: 10.1016/S0140-6736(18)32483-8. NDA New Drug Application, RA rheumatoid arthritis, UC ulcerative colitis. Lancet. JAK-STAT signaling as a target for inflammatory and autoimmune diseases: current and future prospects. Filgotinib is already approved in the European Union as Jyseleca for the treatment of patients with moderate-to-severe active rheumatoid arthritis who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Ann Rheum Dis. In the group of patients who had previously received filgotinib in the induction study (n = 558), clinical remission at week 58 (primary endpoint in the maintenance study) was achieved in a significantly higher proportion of patients treated with filgotinib 200 mg (37.2% vs 11.2%; p < 0.025) or filgotinib 100 mg (23.8% vs 13.5%; p < 0.05) than placebo. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Filgotinib efficacy was sustained up to week 52, with higher ACR20, ACR50 and ACR70 response rates and DAS28-CRP low disease activity and remission rates in the filgotinib 100 mg and 200 mg combination therapy and filgotinib 200 mg monotherapy groups than in the methotrexate group (nominal p < 0.05) [3, 26]. Gilead Sciences. In a pooled analysis of placebo-controlled studies (FINCH 1 and 2 and DARWIN 1 and 2), the incidence of infection during 12 weeks’ treatment with filgotinib 200 mg was 18.1% compared with 13.3% with placebo; no opportunistic infections (excluding tuberculosis) were reported during this period [3]. In February 2018, Galapagos reported that it had exercised its option to co-promote filgotinib in Europe with Gilead [15]. Filgotinib is currently under review by the European Medicines Agency for the treatment of Ulcerative Colitis and is expected to be submitted to Japan in the first half of 2021. Jyseleca: EPAR - public assessment report. Filgotinib significantly decreased levels of circulating biomarkers associated with active AS disease, including proinflammatory cytokines and chemokines, cell adhesion molecules, and markers of matrix remodelling [40]. This article is published under an open access license. Serious infection and herpes zoster were infrequent in all treatment groups [41, 42]. In Japan, filgotinib is indicated for the treatment of RA in patients who had an inadequate response to conventional therapies (including prevention of structural damage to joints) [6]. Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active ankylosing spondylitis (TORTUGA): results from a randomised, placebo-controlled, phase 2 trial. Filgotinib reduced disease activity and signs and symptoms in patients with active AS who were participating in the 12-week, randomized, double-blind, placebo-controlled, phase 2 TORTUGA trial (NCT03117270) [38]. Gilead has also filed for approvals of the drug in Japan and Europe. Mease P, Coates LC, Helliwell PS, et al. In September 2020, filgotinib received its first approvals in the EU and Japan. Tanaka Y, Kavanaugh A, Wicklund J, McInnes IB. ACR50 (32% and 43% vs. 15%; nominal p ≤ 0.001) and ACR70 (14% and 22% vs. 7%; nominal p ≤ 0.05) responses were also more frequent in patients receiving filgotinib 100 mg or 200 mg than in those receiving placebo. Median haemoglobin values remained stable within the normal range during 24 weeks’ treatment in FINCH 1, 2 and 3 [3, 20]. 2020;59(7):1495–504. GLPG0634 was well exposed in rodents upon oral dosing, and exposure levels correlated … Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active ankylosing spondylitis (TORTUGA): results from a randomised, placebo-controlled, phase 2 trial. An interim analysis of DARWIN 3 showed that clinical efficacy of filgotinib is maintained up to week 156, as assessed by ACR20, ACR50 and ACR70 response rates (87%/72%/46% in patients switching from combination therapy and 90%/63%/40% in patients continuing monotherapy), and DAS28-CRP low disease activity and remission rates (69%/53% in patients switching from combination therapy and 65%/46% in patients from continuing monotherapy) [31]. The primary endpoint was the proportion of subjects who achieved an ACR20 response at Week 12 [3, 22]. NDA New Drug Application, RA rheumatoid arthritis, UC ulcerative colitis. Careers. Filgotinib (Jyseleca®) is an oral, ATP-competitive, reversible JAK1 preferential inhibitor that is being developed by Galapagos NV and Gilead Sciences for the treatment of inflammatory autoimmune diseases, including inflammatory arthritis and inflammatory bowel disease. Filgotinib will be available as 100 mg and 200 mg tablets for oral use, and is recommended for … Lancet. Further in vivo investigation of drug-drug interactions between filgotinib and OATP substrates is ongoing. During 12 weeks’ treatment, the incidences of infectious adverse drug reactions in filgotinib 200 mg and placebo groups were 3.3% and 1.8% for URTI, 1.7% and 0.9% for UTI, 0.6% and 0.4% for pneumonia, and 0.1% and 0.3% herpes zoster. For some patients, the disorder progresses slowly. eCollection 2019. Efficacy and safety of filgotinib for patients with rheumatoid arthritis Naive to methotrexate therapy: FINCH3 primary outcome results [abstract no. Filgotinib (200 mg and 100 mg tablets) is approved and marketed as Jyseleca ® in Europe and Japan for the treatment of adults with moderately to … Rheumatoid arthritis treatment with filgotinib: week 156 safety and efficacy data from a phase 2b open-label extension study [abstract no. Given the major role of the JAK-STAT pathway in the pathogenesis of inflammatory diseases, JAKs were considered logical targets for pharmacological manipulation, leading to the development of JAK inhibitors. In December 2019, Gilead Sciences entered into an agreement with Eisai, for the distribution and co-promotion of filgotinib for the treatment of RA in the Japanese market. 25 Sep 2015. https://www.glpg.com, Galapagos. Filgotinib has been accepted for a marketing review by the European Medicines Agency (EMA). ACR50 (36% and 47% vs. 20%) and ACR 70 (19% and 26% vs. 7%) responses were also more frequent in the filgotinib 100 mg and 200 mg groups than in the placebo group (nominal p ≤ 0.001) [3, 22]. Share Article. Gilead Sciences. AbbVie and Galapagos extend GLPG0634 collaboration to include Crohn's disease [media release]. 2021 Feb;81(2):297. doi: 10.1007/s40265-021-01468-3. Please enable it to take advantage of the complete set of features! Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis: finch 3 52-week results [abstract no. European Medicines Agency. Others may never experience worsening symptoms. Filgotinib (GLPG0634) dose-dependently inhibited Th1 and Th2 differentiation and to a lesser extent the differentiation of Th17 cells in vitro. Filgotinib and GS-829845 exposures (area under the concentration-time curve; AUC) and Cmax were similar between healthy adult subjects and patients with RA and values were dose proportional over the therapeutic range. The original version of this article was revised due to a retrospective Open Access order. In July 2019, the deal was amended under the terms of which Gilead and Galapagos were to co-commercialize filgotinib in France, Germany, Italy, Spain and the United Kingdom and retain the 50/50 profit share in these countries. Accessibility LB0003]. Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR). you are unable to locate the licence and re-use information, In FINCH 3, involving methotrexate-naïve patients, the incidence of infections over 24 weeks was 25.2%, 23.1% and 24.5% in patients receiving filgotinib 200 mg monotherapy, filgotinib 200 mg plus methotrexate and methotrexate, respectively, and the incidence of serious infections was 1.4%, 1.0% and 1.0%, respectively. There was no dose dependent effect of filgotinib on serious treatment-emergent adverse events (TEAEs) and TEAEs leading to death, and the exposure-adjusted incidence rates per 100 patient years (EAIRs/100 PYs) of these events were comparable between patients receiving filgotinib 200 mg or 100 mg, adalimumab, methotrexate or placebo (serious TEAEs 6.5, 7.7, 7.6, 7.9 and 9.3; TEAEs leading to death 0.4, 0.4, 0.3, 0 and 0.3). SAT0373]. During the induction and maintenance periods of SELECTION, the incidence of adverse events and serious adverse events with filgotinib in patients with ulcerative colitis was similar to that with placebo. Patients received filgotinib 100 mg or 200 mg once daily plus methotrexate (n = 207 and 416), filgotinib 200 mg monotherapy (n = 210) or methotrexate monotherapy (n = 416). Both the companies were to jointly commercialize filgotinib if approved in Japan [17]. 2013;65(Suppl 10):S209–10. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Durez P, Hoekema A, Huizinga T, et al. In: 21st Annual Congress of the European League Against Rheumatism. In the EU, filgotinib is indicated for the treatment of moderate to severe active RA in adults who have responded inadequately to, or who are intolerant to, one or … Filgotinib — which is approved under the tradename Jyseleca for RA in Europe and Japan — has been plagued in the United States by lingering concerns regarding its testicular toxicity. In a clinical pharmacology study, the majority of radioactivity in plasma was accounted for by filgotinib (2.9%) and GS-829845 (92%), with no other major metabolites identified. 2018;392(10162):2367–77. Efficacy and safety of filgotinib, a selective janus kinase 1 inhibitor, in patients with active psoriatic arthritis: subgroup analyses from a randomized, placebo-controlled, phase 2 trial (Equator) [abstract no. Accessed 30 Sep 2020. A phase 2, open-label long-term extension study (NCT03320876) is evaluating the long-term safety and efficacy of filgotinib in patients with moderately to severely active PsA. In FITZROY, similar proportions of placebo and filgotinib 100 mg or 200 mg recipients with Crohn’s disease experienced at least one treatment-emergent adverse event; 9% of filgotinib (14/152) and 4% of placebo (3/67) recipients experienced a serious treatment-emergent adverse event. Acta Clin Belg. PubMed Google Scholar. Serum C-reactive protein (CRP) levels decreased as early as week 2 of treatment and were maintained over 24 weeks’ treatment with filgotinib. Drugs Context. At week 12, significantly more patients receiving filgotinib 100 mg or 200 mg than those receiving placebo achieved ACR20 (58% and 66% vs. 31%; p < 0.001; primary endpoint). Gilead receives complete response letter for filgotinib for the treatment of moderately to severely active rheumatoid arthritis [media release]. In: 21st Annual Congress of the European League Against Rheumatism. Filgotinib, a novel JAK1-preferential inhibitor for the treatment of rheumatoid arthritis: An overview from clinical trials. Significantly more patients receiving filgotinib 100 mg or 200 mg plus methotrexate combination therapy than those receiving methotrexate monotherapy achieved an ACR20 response at week 24 (80% and 81% vs. 71%; both p < 0.05); there was no significant difference between filgotinib 200 mg monotherapy and methotrexate recipients in the ACR20 response rate (78% vs. 71%) [3, 25]. Ann Rheum Dis. SELECTION is a randomized, double-blind study that evaluated once-daily filgotinib 100 mg or 200 mg versus placebo as (a) induction therapy in patients with moderately to severely active ulcerative colitis who were biologic naïve but failed conventional therapy (Induction Study A; n = 659) or were biologic experienced (Induction Study B; n = 689) and (b) maintenance treatment for patients with moderately to severely active ulcerative colitis who had achieved either clinical remission or Mayo Clinic Score (MCS) response with induction treatment in any of the treatment arms (n = 664). Keshav S, Roblin X, D’Haens G, et al. Efficacy and safety of filgotinib for patients with rheumatoid arthritis with inadequate response to methotrexate: Finch 1 52-week results [abstract no. NDA New Drug Application, RA rheumatoid arthritis, UC…, National Library of Medicine The pharmacokinetics of filgotinib have not been assessed in patients with end stage renal disease (CLCR < 15 mL/min) or severe hepatic impairment (Child-Pugh C) [3]. In the EU, filgotinib is indicated for the treatment of moderate to severe active RA in adults who have responded inadequately to, or who are intolerant to, one or more DMARDs [3]. 22 Feb 2018. https://www.glpg.com. volume 80, pages 1987–1997 (2020)Cite this article, A Correction to this article was published on 02 February 2021. Weng C, Xue L, Wang Q, Lu W, Xu J, Liu Z. Ther Adv Musculoskelet Dis. Efficacy of filgotinib vs placebo in active psoriatic arthritis: patient-level data from equator, a randomized, phase 2 study [abstract no. Ann Rheum Dis. © 2021 Springer Nature Switzerland AG. 2019;78(Suppl 2):259–60. Correspondence to Jyseleca® (filgotinib): Japanese prescribing information. Improvements in HAQ-DI scores with filgotinib 100 mg or 200 mg were significantly greater than with placebo at week 12 (mean change from baseline − 0.48 and − 0.55 vs − 0.23; p < 0.001) and more filgotinib 100 mg or 200 mg than placebo recipients had a HAQ-DI reduction of ≥ 0.22 points (66% and 67% vs. 44%; nominal p < 0.001). 2016;10(1):38–48. Gladman DD, Coates LC, Van den Bosch F, et al. J Immunol. This article summarizes the milestones in the development of filgotinib leading to this first approval. The 52-week randomized, double-blind, active-controlled phase 3 FINCH 3 trial (NCT02886728) showed that filgotinib significantly improved signs and symptoms of disease, physical function and HRQOL, and slowed radiographic progression in methotrexate-naïve patients with moderately to severely active RA [3, 25]. Mease P, Coates LC, Helliwell PS, Stanislavchuk M, Rychlewska-Hanczewska A, Dudek A, Abi-Saab W, Tasset C, Meuleners L, Harrison P, Besuyen R, Van der Aa A, Mozaffarian N, Greer JM, Kunder R, Van den Bosch F, Gladman DD. Filgotinib treatment results in reduction of biomarkers associated with disease in patients with ankylosing spondylitis [abstract no. 2015;66:311–28. Tanaka Y, Van Der Aa A, Jamoul C, et al. Filgotinib is extensively metabolized, primarily by carboxylesterase (CES) 2, and to a lesser extent by CES1, to form the main circulating metabolite GS-829845 [3]. The tolerability profile of filgotinib was consistent with its mechanism of action and no new safety concerns were identified [46]. Annu Rev Med. The companies agreed to a lock-up and standstill arrangement, which was to expire on 31 December 2017 [14]. Posts about filgotinib written by DR ANTHONY MELVIN CRASTO Ph.D. New Drug Approvals All about Drugs, live, by DR ANTHONY MELVIN CRASTO, Worlddrugtracker, OPEN SUPERSTAR Helping millions, 10 million hits on google, pushing boundaries,2.5 lakh plus connections worldwide, 29 lakh plus VIEWS on this blog in 223 countries, 7 CONTINENTS The views expressed are my personal and in no-way … The effect of filgotinib on key efficacy measure, including ACR20, ACR50 and ACR70 responses, were generally consistent across subgroups, regardless of patient, disease and treatment characteristics [34]. Unable to load your collection due to an error, Unable to load your delegates due to an error, Key milestones in the development of filgotinib. 2020. Lancet. Clipboard, Search History, and several other advanced features are temporarily unavailable. Recruitment is underway for the phase 3, randomized, double-blind PENGUIN 1 trial (NCT04115748), which will compare the efficacy and safety of filgotinib versus placebo and adalimumab in patients with active PsA who are naïve to biologic DMARDs. Filgotinib is under regulatory review for use in ulcerative colitis in the EU [8]. Filgotinib modulates the JAK-STAT signalling pathway by preventing the phosphorylation and activation of STATs. JAKs are cytoplasmic tyrosine kinases that associate with cytokine receptors and transduce cytokine signalling via phosphorylation of STATs [2]. Vermeire S, Schreiber S, Petryka R, et al. Abbott and Galapagos announce global collaboration for novel oral therapy, GLPG0634, in phase II to treat autoimmune diseases [media release]. doi: 10.1007/s40265-017-0701-9. FOIA AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond. In: 21st Annual Congress of the European League Against Rheumatism. Filgotinib (Jyseleca®): summary of product characteristics. Upadacitinib and filgotinib: the role of JAK1 selective inhibition in the treatment of rheumatoid arthritis. 24 Dec 2019. https://www.gilead.com. Patients receiving filgotinib reported significantly greater and clinically meaningful improvements in patient-reported outcomes at week 16, including improvements in the PsA Impact of Disease 9 questionnaire (PsAID9) [35], Patient’s Global Assessment of Disease Activity, pain, HAQ-DI, FACIT-F and SF-36 PCS (all p < 0.01), but not in the SF-36 Mental Summary (MCS) [36]. NCI CPTC Antibody Characterization Program, Banerjee S, Biehl A, Gadina M, et al. These enzymes play an important role in the inflammatory process that occurs in rheumatoid arthritis. 2021 Mar 21;13:1759720X21999564. GlobalData expects that filgotinib will receive regulatory approval from the European Medicines Agency (EMA) in Q3 this year, having received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2020. Article  2020. https://www.ema.europa.eu/. Combe B, Kivitz A, Tanaka Y, et al. Efficacy and safety of filgotinib for patients with rheumatoid arthritis with inadequate response to methotrexate: FINCH 1 primary outcome results. In the US, Gilead received a complete response letter (CRL) from the FDA in August 2020 in the context of the agency’s evaluation of the product’s marketing authorization for RA. European medicines agency validates marketing application for Filgotinib for the treatment of Ulcerative Colitis . The preparation of this review was not supported by any external funding. Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.13191509. Patients were randomized to receive filgotinib 100 mg or 200 mg once daily (n = 480 and 475), adalimumab 40 mg every 2 weeks (n = 325) or placebo (n = 475) in addition to stable background treatment with methotrexate. Drugs. On 24 September 2020, filgotinib received its first approvals in the EU [3] and Japan [5]. Would you like email updates of new search results? The mean change from baseline in HAQ-DI at week 24 was significantly (p ≤ 0.01) greater with filgotinib 100 mg or 200 mg plus methotrexate than with methotrexate (− 0.90 and − 0.94 vs − 0.79) [3, 25]. Serious infections occurred in four filgotinib recipients and no placebo recipients [43]. DeclarationsFunding The preparation of this review was not supported by any external funding.Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Please check the 'Copyright Information' section either on this page or in the PDF - 67.227.198.216. The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. Drugs. Filgotinib demonstrates durable efficacy and consistent safety profile … The JAK-STAT signalling pathway has been implicated in the pathogenesis of inflammatory and autoimmune diseases, and filgotinib modulates this pathway by preventing the phosphorylation and activation of STATs. Part of Springer Nature. 2020. Permissions team, https://doi.org/10.1007/s40265-020-01439-0, An oral, ATP-competitive, reversible JAK1 preferential inhibitor being developed by Galapagos NV and Gilead Sciences for the treatment of inflammatory autoimmune diseases, Received its first approval on 24 September 2020 in the EU and Japan, Approved for the treatment of RA in adults who have responded inadequately to, or who are intolerant to, one or more DMARDs, Filgotinib hydrochloride; G-146034; G-146034-101; GLPG-0634; GS-6034; Jyseleca, 2 ring heterocyclic compounds; amides; anti-inflammatories; antirheumatics; cyclopropanes; pyridines; skin disorder therapies; small molecules; thiamorpholines; triazoles; urologics, Modulates the JAK-STAT pathway by preventing the phosphorylation and activation of STATs, Preferentially inhibits the activity of JAK1 over JAK2, JAK3 and TYK2, Inhibited JAK1/JAK3-mediated IL-2, IL-4 and IL-15 signalling, JAK1/2-mediated IL-6 signalling and JAK1/TYK2-mediated type I interferon signalling in human cellular assays, Dose-dependently inhibited IL-6-induced STAT1 phosphorylation in human whole blood assays, Peak plasma concentration reached in 2–3 h, Filgotinib and GS-829845 (main metabolite) steady state reached in 2–3 and 4 days, respectively, Mean terminal half-lives of filgotinib and GS-829845 approximately 7 and 19 h, respectively, Nausea, upper respiratory tract infection, urinary tract infection, dizziness, Filgotinib, adalimumab, placebo, methotrexate. The onset of response to filgotinib was early, with a median time to first ACR20 response of 4.1 weeks in the filgotinib group compared with 12.3 weeks in the placebo group (p < 0.0001) [33]. 19 Jan 2016. https://www.glpg.com, Galapagos. LB19]. Effect of filgotinib, a selective JAK 1 inhibitor, with and without methotrexate in patients with rheumatoid arthritis: patient-reported outcomes. Patients entering the maintenance study who had received filgotinib induction therapy were re-randomized to receive either their induction filgotinib dose or placebo; patients who had received placebo in the induction study continued placebo in the maintenance study. In January 2016, the company reported closing of the deal and entry into force [13]. In: 21st Annual Congress of the European League Against Rheumatism. Integrated safety analysis of filgotinib treatment for rheumatoid arthritis from 7 clinical trials [abstract no. Galapagos had retained co-promotion rights in Belgium, the Netherlands and Luxembourg [4, 9]. In contrast, on September 25, 2020, the European Commission granted EU marketing authorization for filgotinib under the trade name Jyseleca® for the treatment of adults with moderate-to-severe active rheumatoid arthritis; on the same day, the Japanese Ministry of Health, Labor and Welfare also granted regulatory approval for filgotinib. Lucy Parsons. Recruitment is also underway for the phase 3, randomized, double-blind, placebo-controlled PENGUIN 2 trial (NCT04115839), which will determine the efficacy and safety of filgotinib in patients with active PsA who have an inadequate response or are intolerant to biologic DMARDs. Outside of the United States, filgotinib was approved for rheumatoid arthritis by the European Medicines Agency (EMA). Exposure to filgotinib and GS-829845 was increased in patients with moderate (CLCR 30 to < 60 mL/min) or severe (CLCR 15 to < 30 mL/min) renal impairment; therefore, a filgotinib 100 mg once daily dose is recommended in these patients. Galapagos. Effect of filgotinib vs placebo on clinical response in patients with moderate to severe rheumatoid arthritis refractory to disease-modifying antirheumatic drug therapy: the FINCH 2 randomized clinical trial. Rheumatoid Arthritis (RA) Rheumatoid arthritis is a chronic inflammatory disorder which impacts joints. Genovese M, Westhovens R, Meuleners L, et al. Share. Lancet. 2015;66:311–328. Filgotinib is an investigational agent and is not approved for use by any regulatory authority. Peyrin-Biroulet L, Loftus Jr EV, Danese S, et al. Kavanaugh A, Kremer J, Ponce L, et al. In biochemical assays, filgotinib selectively inhibited the activity of JAK1 (> 5-fold higher potency) over JAK2, JAK3 and TYK2. In September 2020, filgotinib received its first approvals in the EU and Japan. Kavanaugh A, Westhovens R, Winthrop K, et al. Filgotinib is approved for the treatment of RA by the EMA and PMDA. It does this by blocking the action of enzymes known as Janus kinases (JAKs). FRI0343]. The FINCH Phase 3 program investigated the efficacy and safety of filgotinib 100 mg and 200 mg once-daily, in RA patient populations ranging from early stage to biologic-experienced patients. At 24 weeks, patients receiving filgotinib 100 mg or 200 mg plus methotrexate or filgotinib 200 mg monotherapy had higher (nominal p < 0.01) ACR50 (57%, 62% and 58% vs. 46%) and ACR70 (40%, 44% and 40% vs. 26%) response rates, and DAS28-CRP low disease activity (63%, 69% and 60% vs. 46%) and significantly higher DAS28-CRP remission (43%, 54% and 42% vs. 29%; p ≤ 0.001) rates than patients receiving methotrexate [3, 25]. In Japan, filgotinib is indicated for the treatment of RA in patients who had an inadequate response to conventional therapies (including prevention of structural damage to joints).