Gilead/Galapagos’ Oral JAK1 Inhibitor Jyseleca Approved in the UK for New Indication in Ulcerative Colitis
Jan 20, 2022 00:38
CST Updated
00:38
Gilead Sciences
Antiviral Drug Developer
Galapagos
Small Molecule and Antibody Therapeutics Developer
Medicines and Healthcare products Regulatory Agency
The MHRA is an executive agency of the UK Department of Health and Social Care, responsible for ensuring that medicines and medical devices work effectively and are safe and reliable. Established in 2003 through the merger of the Medicines Control Agency and the Medical Devices Agency, the organization employs more than 1,300 staff members.
Ulcerative Colitis (UC, Image Source: healthjade.com)
News on January 19, 2022 /BioValleyBIOON/ -- Gilead Sciences' partner Galapagos NV recently announced that the UK Medicines andHealth ProductsThe Administration (MHRA) has approvedOral Anti-Inflammatory Drug Jyseleca (Filgotinib, 200mg Tablets)A new indication,This medication is a once-daily oral JAK1 preferential inhibitor, indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or biologics.。
The MHRA's approval decision follows the European Commission (EC) decision to approve Jyseleca for the treatment of the same patient population. In the European Union, Jyseleca received approval for the aforementioned new indication in November 2021. Jyseleca will provide a new treatment option for patients with moderate to severe active UC. Currently, the application for Jyseleca's UC indication is also under review by Japanese regulatory authorities.
Jyseleca is an oral selective JAK1 inhibitor that has been approved for marketing in the EU, UK, and Japan (Jyseleca 100mg and 200mg tablets) for the treatment of moderate to severe rheumatoid arthritis in patients with inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).Rheumatoid Arthritis(RA) adult patients. In terms of medication, Jyseleca can be used as monotherapy or in combination with methotrexate (MTX).
Notably, in September 2021, AbbVie submitted to the United StatesFDASubmitted a new indication application for the oral JAK1 inhibitor Rinvoq (upadacitinib) to the EU EMA: for the treatment of adult patients with moderate to severe active UC. Rinvoq is also an oral selective JAK1 inhibitor.
MHRA Approves Jyseleca Based on Data from the Pivotal Phase 2b/3 SELECTION Program. This program evaluated the efficacy and safety of Jyseleca as an induction and maintenance therapy in adult patients with moderately to severely active UC who had failed conventional or biologic therapies.
SELECTION includes two placebo-controlled induction studies, one in biologic-naive patients (those who have not previously received biologics) and the other in biologic-experienced patients (those who have previously received biologics), followed by a 47-week maintenance study in patients who responded to Jyseleca after 10 weeks of treatment. Placebo responders continued on blinded placebo during the maintenance period.
Results of the SELECTION trial were recently published in The Lancet. For details, see:Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial。
Molecular structure of filgotinib (Source: Wikipedia)
Ulcerative Colitis (UC) is a chronic inflammatory bowel disease (IBD), characterized by inflammation of the submucosal layer of the colon and rectum. The symptoms of this condition are often intermittent, causing patients to experience periods of flare-ups and remission. In addition to its physical impact, the disease also brings significant psychological effects.
The active pharmaceutical ingredient of Jyseleca is filgotinib, a highly selective JAK1 inhibitor discovered and developed by Galapagos. In late December 2015, Gilead entered into an agreement with Galapagos worth up to $2 billion to co-develop and commercialize filgotinib globally. However, due to significant regulatory setbacks in the United States, the two parties revised the commercialization and development agreement for filgotinib in December 2020. Galapagos will take charge of commercializing filgotinib in Europe (with the transition period concluding by the end of 2021), while Gilead will continue to be responsible for filgotinib in regions outside Europe, including Japan (where Gilead co-markets filgotinib with Eisai).
Currently, filgotinib is being developed for the treatment of various inflammatory diseases, with phase 3 studies including treatment forRheumatoid Arthritis, Crohn's disease, ulcerative colitis. However, in the JAK inhibitor field, filgotinib also faces competition from multiple products, aside from the two already on the market.PfizerXeljanz andEli LillyBesides Olumiant, the stronger competitor will be AbbVie's Rinvoq (upadacitinib). (Bioon.com)