Filgotinib

Galapagos announces topline results from Phase 3 DIVERSITY trial of filgotinib in Crohn’s disease

Retrieved on: 
Wednesday, February 8, 2023
CET, Cohort study, Galapagos NV, Disease, RA, JAK1, Safety, MD, Filgotinib, Axial spondyloarthritis, Euronext, UZ Leuven, UC1, University of Leuven, University, Patient, UC, Crohn's disease, Week, Maintenance, Marketing, Research, Doctor of Philosophy, Pharmaceutical industry, Immunology, Galápagos Islands, Cohort

Induction Cohort A included biologic-naïve (54%) and biologic-experienced (46%) patients; induction Cohort B included biologic-experienced patients.

Key Points: 
  • Induction Cohort A included biologic-naïve (54%) and biologic-experienced (46%) patients; induction Cohort B included biologic-experienced patients.
  • In total, 33% of patients in Cohort A and 52% of patients in Cohort B had failed treatment with 3 or more biologic drugs.
  • Both induction cohorts of the study failed to meet the co-primary endpoints of clinical remission and endoscopic response for filgotinib, 100mg and 200mg once daily.
  • We are grateful to the patients and all medical professionals who participated in this trial.”

Galapagos announces changes to Executive Committee

Retrieved on: 
Thursday, December 22, 2022
IPO, General counsel, Commercial, Executive Committee, Gilead, CET, Barakat Pharmaceutical Group, Head, Executive, Rheumatoid arthritis, GSK, Annelies, Galapagos NV, Valeria, Johnson & Johnson, Retirement, Growth, Filgotinib, Business development, Safety, D, National Executive Committee of the Labour Party, Union, Ulcerative colitis, Euronext, Corporation, Belgian Office for Intellectual Property, Management, Pharmaceutical industry, Galápagos Islands, Ethics, Research

Mechelen, Belgium; 22 December 2022, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced changes in the Executive Committee effective 1 January 2023.

Key Points: 
  • Mechelen, Belgium; 22 December 2022, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) today announced changes in the Executive Committee effective 1 January 2023.
  • Dr. Walid Abi-Saab has decided to retire from the company as Chief Medical Officer and member of the Executive Committee, effective 31 December 2022.
  • He will stay with Galapagos until 31 May 2023 to ensure a smooth transition.
  • The company also announces the retirement of André Hoekema who joined Galapagos in 2005 as Chief Business Officer and member of the Executive Committee.

Galapagos to present encouraging initial data from FILOSOPHY real-world arthritis study at ACR Convergence 2022

Retrieved on: 
Tuesday, November 8, 2022
AES, Rheumatoid arthritis, Disease-modifying antirheumatic drug, Ulcerative colitis, Interview, Adult, Pros, EULAR, Form 1099, Ministry of Health, Labour and Welfare, Safety, Risk, UC, Galapagos NV, Contraindication, Fatigue, Șaeș, European, Gilead Sciences, Union, D, Disease, Product, EPRO, Patient, Pain, Ageing, Pharmaceutical industry, Filgotinib, Health

The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu .

Key Points: 
  • The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu .
  • FILOSOPHY (FILgotinib Observational Study Of Patient Health-related outcomes), is a prospective, observational, non-interventional cohort Phase 4 study enrolling approximately 1500 patients aged 18 years with moderately to severely active RA across Europe.
  • Each enrolled patient will be followed for 24 months or until discontinuation of the study, whichever occurs first.
  • Our first medicine for rheumatoid arthritis and ulcerative colitis is available in the European Union, Norway, Great Britain, and Japan.

Galapagos presents roadmap for pipeline and commercial growth at its R&D Day 2022

Retrieved on: 
Friday, November 4, 2022
UC, CPK, Kidney disease, Lipid, Investigational New Drug, Investment, Saitama (city), Board, BCMA, FDA, D, CD, Safety, IND, Interferon, Fibrosis, SLE, Quality of life, CD19, RA, Intention, Rheumatoid arthritis, EULAR, Inflammatory bowel disease, CET, CEO, Filgotinib, JAK1, Gilead Sciences, Ulcerative colitis, NASDAQ, Jaki, Galapagos NV, Rheumatism, Union, Euronext, Psoriasis, Axial spondyloarthritis, Kidney, TYK2, JAK2, Patient, Renewable energy, Fine chemical, Pharmaceutical industry, Medical imaging, Vaccine, Dermatomyositis

Our renewed focus on two strategic therapeutic areas goes hand in hand with redirecting our resources.

Key Points: 
  • Our renewed focus on two strategic therapeutic areas goes hand in hand with redirecting our resources.
  • Aligned with our Vision 2028, we presented our financial outlook and capital allocation strategy at our R&D Day 2022.
  • We also presented our Vision 2028 roadmap for oncology at our R&D Day 2022.
  • Our first medicine for rheumatoid arthritis and ulcerative colitis is available in the European Union, Norway, Great Britain, and Japan.

Galapagos announces strategy to accelerate innovation and reports strong third quarter 2022 results

Retrieved on: 
Thursday, November 3, 2022
Real-World Evidence, Depreciation, UC, Exercise, Hospital, Sale, Saitama (city), EDT, D, Investor, CD, Safety, SLE, ASH, PRAC, CD19, RA, IPF, Income, Czech Republic, Mission statement, Pharmacology, CHMP, Baltic, Acceleration, S&M, TYK2, Patient, Drug discovery, Pharmaceutical industry, Renewable energy, Aquaculture, Cryptocurrency, Filgotinib, Galápagos Islands, Dermatomyositis, Central Europe

Cost of sales related to Jyseleca net sales in the first nine months of 2022 amounted to 7.9 million.

Key Points: 
  • Cost of sales related to Jyseleca net sales in the first nine months of 2022 amounted to 7.9 million.
  • Collaboration revenues amounted to 349.7 million for the first nine months of 2022, compared to 311.7 million for the first nine months of 2021.
  • Depreciation and impairment amounted to 35.6 million for the first nine months of 2022 (14.1 million for the same period last year).
  • Galapagos financial report for the first nine months ended 30 September 2022, including details of the unaudited consolidated results, is accessible on the financial reports section of our website .

Galapagos provides further insights into the treatment of ulcerative colitis at the upcoming United European Gastroenterology (UEG) Week 2022 congress

Retrieved on: 
Thursday, October 6, 2022
Quality of life, JAK1, LinkedIn, Union, Disease, Mayo Clinic, Rheumatoid arthritis, Population, Diagnosis, Mayo, Patient, MCS, Twitter, Inflammation, Gilead Sciences, Ulcerative colitis, D, TNF, Lancet, Galapagos NV, Disease-modifying antirheumatic drug, Ministry of Health, Labour and Welfare, UC, Induction, IBD, Safety, Adult, Interview, Product, RA, European, Fibrosis, Week, Contraindication, Inflammatory bowel disease, Â, Tablet, Pharmaceutical industry, Filgotinib, Health

3 min discussion)

Key Points: 
  • 3 min discussion)
    Predictors of response to filgotinib in ulcerative colitis: post hoc analysis from the SELECTION study
    Presentation time: 14:36 14:42 (6 min incl.
  • Across Europe an estimated 2.5 - 3 million people1 are affected by IBD, which includes UC and Crohns disease (CD).
  • In addition to the physical impact from flare ups, there is also a psychological impact associated with UC.
  • Our first medicine for rheumatoid arthritis and ulcerative colitis is available in the European Union, Norway, Great Britain, and Japan.

Galapagos receives positive CHMP opinion for Jyseleca® European label update based on testicular function safety data from MANTA/RAy studies

Retrieved on: 
Monday, October 3, 2022
Ministry of Health, Labour and Welfare, Committee for Medicinal Products for Human Use, Gilead Sciences, Interview, Risk management plan, Man, Product, Type, Week, Galapagos NV, MANTA, IBD, EMA, UC, Committee, NASDAQ, RA, Ankylosing spondylitis, Disease-modifying antirheumatic drug, Patient, CET, European Medicines Agency, Inflammatory bowel disease, Inflammation, RC, Adult, Physician, Reproduction, D, Fertility, Advanced Accelerator Applications, Twitter, Fibrosis, Ulcerative colitis, Medication package insert, Semen, JAK1, Tablet, Rheumatoid arthritis, LinkedIn, RMP, Disease, CHMP, Male, CD, Safety, Union, Euronext, Language, Contraindication, Pharmaceutical industry, Birth control, Medical imaging, Galápagos Islands, Filgotinib, European, Health

We will now work to update all relevant label information and materials with the aim to increase access to Jyseleca so that European patients who may benefit from the treatment are able to receive it.

Key Points: 
  • We will now work to update all relevant label information and materials with the aim to increase access to Jyseleca so that European patients who may benefit from the treatment are able to receive it.
  • Further, CHMP concluded that the data did not show any relevant changes in sex hormone levels or change from baseline in semen parameters across treatment groups.
  • Overall, CHMP concluded that these clinical data were not suggestive of filgotinib-related effects on testicular function.
  • Our first medicine for rheumatoid arthritis and ulcerative colitis is available in the European Union, Norway, Great Britain, and Japan.

Ulcerative Colitis Market Forecasts, Epidemiology & Pipeline Analysis 2022-2027: Focus on 8 Major Markets - United States, France, Germany, Italy, Spain, United Kingdom, China, and Japan - ResearchAndMarkets.com

Retrieved on: 
Tuesday, August 30, 2022
Biotechnology, Pharmaceutical, Health, AbbVie, NDA, Inflammatory bowel disease, UC, Safety, Mirikizumab, Research, Warfarin necrosis, Therapy, Filgotinib, Awareness, US Foods, Ulcerative colitis, Man, Galápagos Islands, Allergan, Novartis, USFDA, Disease management, Pfizer, Investment, Disease, David Berry (inventor), Takeda Pharmaceutical Company, Prevalence, FDA, CAGR, Johnson & Johnson, Knowledge, Clinical trial, Woman, Acquisition, Growth, Industry, Patient, Pharmaceutical industry, Dietary supplement, Fine chemical, Health insurance, Adalimumab, Upadacitinib, Proctitis, Epidemiology, Ulcer, Phase

The ulcerative colitis epidemiology provides insights into the historical and current patient pools and forecasted trends for eight (8MM) major countries.

Key Points: 
  • The ulcerative colitis epidemiology provides insights into the historical and current patient pools and forecasted trends for eight (8MM) major countries.
  • The Ulcerative colitis epidemiology data are studied through all possible divisions to give a better understanding of the disease scenario in 8MM.
  • The increasing prevalence of ulcerative colitis is driving the growth of the ulcerative colitis drug market.
  • Launch of New Therapies: The USFDA approved small molecules such as Jyseleca (Filgotinib) and Rinvoq (Upadacitinib) in 2022 to treat moderate-to-severe ulcerative colitis.

New IBD Mechanisms of Action Are Poised to Gain EU5 Patient Switches as Anti-TNF Therapy Efficacy Fades in Ulcerative Colitis and Crohn's Disease, According to Spherix Global Insights

Retrieved on: 
Tuesday, August 16, 2022
Molecule, Crohn's disease, Infliximab, Diagnosis, Failure, AbbVie, CD, MOA, Gastroenterology, BMS, Patient, NASA RealWorld-InWorld Engineering Design Challenge, TNF, Safety, JAK, Nephrology, Ustekinumab, Ulcerative colitis, Janssen, Adalimumab, Upadacitinib, Time, Kwaku Amoa-Awuah, EMA, Pharmaceutical industry, Medical imaging, Generic drug, IBD, Ozanimod, Filgotinib, UC, EU

EXTON, Pa., Aug. 16, 2022 /PRNewswire/ -- According to the latest report published as part of Spherix's RealWorld Dynamix™: Biologic/Small Molecule Switching in IBD (EU) service, EU gastroenterologists (n=285) have accelerated their switching of ulcerative colitis (UC) and Crohn's disease (CD) patients from anti-TNF therapies to treatments that include new pathways such as IL12/IL23 inhibition, α4β7 integrin binding, JAK inhibition, and S1P modulation.The Spherix study includes 1,280 unique IBD patient records from the EU5 (France, Germany, Italy, Spain, and the UK) that encapsulate patient-level data.

Key Points: 
  • The report also identifies a significant level of opportunity that still exists for new pathways and agents in IBD.
  • More specifically, 27% of UC patients and 30% of CD patients who have recently switched did so because of secondary efficacy failure.
  • The biosimilar therapies (infliximab and adalimumab) are the two treatment options most likely to trigger an efficacy-based switch.
  • In fact, when combining biosimilars and brands, TNF therapy represents the switch-from agent for a majority of all UC and CD patients.

First key steps in pipeline rebuild and strong commercial progress in H1 2022

Retrieved on: 
Thursday, August 4, 2022
Committee for Medicinal Products for Human Use, Q&A, Adoption, Exercise, Drug discovery, FTE automotive, IPF, Committee, European Directive on Traditional Herbal Medicinal Products, Sale, RA, MANTA, Hospital, UC, Income, Baltic, Patient, Mission statement, D, Depreciation, CHMP, Czech Republic, TYK2, Royal commission, European Commission, Saitama (city), Pharmacovigilance, Drug, Tutoring, Pharmaceutical industry, Renewable energy, Aquaculture, Cryptocurrency, Dermatomyositis, Filgotinib, Galápagos Islands, Central Europe

Cost of sales related to Jyseleca net sales in the first six months of 2022 amounted to 5.5 million.

Key Points: 
  • Cost of sales related to Jyseleca net sales in the first six months of 2022 amounted to 5.5 million.
  • Collaboration revenues amounted to 238.6 million for the first six months of 2022, compared to 253.2 million for the first six months of 2021.
  • Depreciation and impairment amounted to 32.6 million for the first six months of 2022 (8.1 million for the same period last year).
  • The preliminary accounting of the acquisitions of CellPoint and AboundBio are included in our H1 2022 condensed consolidated financial statements.