Galapagos - Model Filgotinib - Galapagos Using Our Proprietary Target and Drug Discovery Technology Platform
Filgotinib, a preferential JAK1 inhibitor, is marketed as Jyseleca in the European Union (incl. Norway), Great Britain, and Japan for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).
Details
Filgotinib is also marketed as Jyseleca in the European Union (incl. Norway), Great Britain, and Japan for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Jyseleca (filgotinib) 100mg and 200mg are registered in the above-mentioned territories. A global Phase 3 program with filgotinib is ongoing in Crohn’s Disease.
Rheumatoid Arthritis (RA)
In September 2020, filgotinib 200mg and 100mg (Jyseleca) obtained approval in the European Union, Great Britain, and Japan for the treatment of adult patients with moderate to severe active RA.
In the US, Gilead received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for filgotinib in 2020. Consequently, Gilead decided not to advance with the resubmission in the US for approval of filgotinib as a treatment for RA.
Ulcerative Colitis (UC)
In May 2020, Gilead and Galapagos announced positive topline results with filgotinib in the Phase 3 SELECTION trial in UC. Following this, Filgotinib 200mg (Jyseleca) has been approved in November 2021 for the treatment of adults with moderate to severe UC in the European Union, in January 2022 in Great Britain and in March 2022 in Japan.
Crohn’s disease (CD)
A Phase 3 study to evaluate the efficacy and safety of filgotinib in Crohn's disease is currently ongoing (CD, DIVERSITY). In October 2021, we announced the completion of patient enrolment with topline data anticipated in the first half of 2023.
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