Progress with immunology and oncology pipeline: First patients dosed in pivotal Phase 3 OLINGUITO study with filgotinib in axial spondyloarthritis (AxSpA)Clinical sites opened to start...
Galapagos initiates Phase 3 program with filgotinib in patients with active axial spondyloarthritis
Mechelen, Belgium; 8 February 2023, 22:01 CET; regulated information; Galapagos NV (Euronext & NASDAQ: GLPG) today announced the topline results from DIVERSITY, a global Phase 3 trial to evaluate the safety and efficacy of filgotinib, 100mg or 200mg once daily, during induction and maintenance treatment of biologic-naïve and biologic-experienced patients with moderate to severe Crohn's disease (CD).
Advisers to the European Medicines Agency on Friday recommended limiting the use of a group of widely prescribed inflammatory disease drugs due to safety concerns, following a similar, but more restrictive ruling last year by regulators in the U.S.
Mechelen, Belgium; 3 November 2022, 21.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) today announced its strategy for accelerated growth and value creation, its financial results for the first nine months of 2022, and the outlook for the remainder of 2022. The results are further detailed in the Q3 2022 financial report available on the financial reports section of the website.
Janus kinase inhibitors used for chronic inflammatory conditions are only safe for certain patients, advises the EMA’s safety committee.
Following the US’ lead, the EMA is cutting back on the use of JAK inhibitors for some patients over a suite of safety concerns.
London, UK, 10 October 2022 – Galapagos Biotech LTD announces that the Scottish Medicines Consortium (SMC) has recommended the use of filgotinib, a once daily, oral, JAK1 preferential inhibitor, for adults who have previously been treated for moderate RA. The decision expands access to filgotinib to the estimated 14,000 people in Scotland who live with the moderate form of the disease and from today, eligible patients will be able to gain access via the health service.
Mechelen, Belgium; 18 January 2022; 22.01 CET; Galapagos NV (Euronext & Nasdaq: GLPG) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Jyseleca® (filgotinib 200mg tablets), as a new treatment for ulcerative colitis (UC) for Great Britain.
Mechelen, Belgium; 15 November 2021; 16.45 CET; Galapagos NV (Euronext & Nasdaq: GLPG) announced today that the European Commission has granted marketing authorization for Jyseleca® (filgotinib 200mg tablets) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).