Gilead Sciences, Inc. and Galapagos NV announced that the European Commission (EC) has granted marketing authorization for Jyseleca® (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately to, or are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).
RA is a chronic, progressive, systemic, inflammatory disease that can lead to significant and irreversible joint destruction, pain and functional impairment. Almost 3 million people in Europe are living with RA many of whom do not achieve long-term symptom control, which can lead to more frequent symptom flares and disease progression and can significantly impact their quality of life.
“Despite the availability of existing therapies, new treatment options are still needed to help optimally manage the impact of RA on patients’ daily lives. Jyseleca has demonstrated robust symptom control and prevention of disease progression with a consistent safety profile across the clinical development program. This marketing authorization provides a welcome new option for people in Europe living with this debilitating and complex disease,” said Peter C. Taylor, MA, BM, BCh, PhD, FRCP, Professor of Musculoskeletal Sciences at the University of Oxford.
The EC’s decision is supported by data from more than 3,500 patients treated with Jyseleca across the Phase 3 FINCH and Phase 2 DARWIN programs. In the FINCH studies, Jyseleca consistently achieved ACR20/50/70 criteria, with improvements in all individual ACR components compared with placebo or MTX.
A significantly higher proportion of patients treated with Jyseleca 200 mg plus MTX or other conventional synthetic disease-modifying anti-rheumatic drug(s) (csDMARD) achieved low disease activity and/or remission (DAS28-CRP≤3.2 and DAS28-CRP<2.6) at Weeks 12 and 24 compared with placebo or MTX.
In patients who had an inadequate response to MTX, treatment with Jyseleca plus MTX achieved statistically significant inhibition of progression of structural joint damage compared with placebo plus MTX, as assessed using the modified Total Sharp Score (mTSS) at Week 24. In the DARWIN 3 Phase 2, open-label, long-term extension study, durable ACR20/50/70 responses were maintained for up to three years in patients who received Jyseleca 200 mg as monotherapy or with MTX.
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 Jyseleca 200 mg 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 Jyseleca were comparable to placebo. The rates of serious infections remained stable with long-term exposure.
“Jyseleca, the first medicine from Galapagos to obtain regulatory approval is the result of a strong commitment to addressing unmet medical need,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “We look forward to making continued progress through our collaboration with Galapagos so we can help to deliver many new solutions for patients in the future.”
“Today’s announcement is a proud day for everyone at Galapagos, recognizing years of research and commitment to make a meaningful change in the lives of patients struggling with the symptoms of RA,” said Onno van de Stolpe, Chief Executive Officer, Galapagos. “This news further affirms the efficacy and safety profile of Jyseleca, and we look forward to bringing this important treatment to physicians and patients across Europe as quickly as possible.”
Under the collaboration agreement, Galapagos will now receive a milestone payment of $75 million in recognition of the approval of Jyseleca by the European Commission.
About the FINCH Program
The FINCH Phase 3 program investigated the efficacy and safety of Jyseleca 200 mg and 100 mg once-daily, in RA patient populations ranging from early stage to biologic-experienced patients. FINCH 1 was a 52 week, randomized, placebo- and adalimumab-controlled trial in combination with MTX, enrolling 1,759 adult patients with moderate to severe active RA who had inadequate response to MTX. The primary endpoint in FINCH 1 was ACR20 at Week 12. The trial included radiographic assessment at Weeks 12, 24 and 52. FINCH 2 was a global, 24-week, randomized, double-blind, placebo-controlled, Phase 3 study evaluating Jyseleca on a background of csDMARDs among 449 adult patients with moderate to severe active RA who had not adequately responded to biologic DMARDs (bDMARDs). The primary endpoint in FINCH 2 was ACR20 at Week 12. FINCH 3 was a 52 week, randomized trial in 1,252 MTX-naïve patients to evaluate Jyseleca 200 mg alone and Jyseleca 200 mg or 100 mg combined with MTX versus MTX alone in MTX-naïve patients. The primary endpoint in FINCH 3 was ACR20 at Week 24. The trial included radiographic assessment at Weeks 24 and 52.
About the Filgotinib Collaboration
Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib in RA and other inflammatory indications. The companies are conducting global studies investigating the potential role of Jyseleca in a variety of diseases, including the previously reported Phase 3 SELECTION trial in ulcerative colitis.
More information about clinical trials with Jyseleca can be accessed at: www.clinicaltrials.gov.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
Galapagos NV discovers and develops small molecule medicines with novel modes of action, three 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, osteoarthritis 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.