Ulcerative colitis (UC, Image source: healthjade.com)
September 18, 2021 /
BioonBIOON/ -- Galapagos NV, a partner of Gilead Sciences, recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval
Jyseleca (filgotinib, 200 mg), an oral anti-inflammatory drug, is a once-daily oral JAK1-preferring inhibitor indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response, or intolerance to conventional therapy or biologics.
Now, the CHMP opinion will be submitted to the European Commission (EC) for review, which typically issues a final decision within two months. If approved, Jyseleca will provide a new treatment option for patients with moderate to severe active UC in the EU. Notably,
Due to safety concerns, the United StatesFDAJyseleca has not yet been approved for any indications.
Jyseleca is an oral selective JAK1 inhibitor approved for marketing in the European Union, the United Kingdom, and Japan, for the treatment of moderate-to-severe rheumatoid arthritis in patients with an inadequate response to or intolerance of one or more disease-modifying antirheumatic drugs (DMARDs).Rheumatic arthritis(RA) adult patients.Regarding treatment, Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). Currently, the regulatory review for the UC indication application of Jyseleca is also underway in the UK and Japan,
It is worth noting that, just recently,
AbbVie to the USFDAand submitted the oral JAK1 inhibitor Rinvoq to the EU EMA(upadacitinib) new indication application: for the treatment of adult patients with moderately to severely active UC. Rinvoq is also an oral selective JAK1 inhibitor.
The CHMP's positive opinion is 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 adults with moderately to severely active ulcerative colitis (UC) who had an inadequate response, loss of response, or intolerance to conventional therapy or biologics. SELECTION included two placebo-controlled induction studies, one in biologic-naïve patients and the other in biologic-experienced patients, followed by a 47-week maintenance study in patients who responded to Jyseleca after 10 weeks of treatment. Placebo responders continued to receive blinded placebo during the maintenance period. The 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。
Filgotinib molecular structure (Image source: Wikipedia)
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD). Its symptoms are often intermittent, so patients typically experience periods of flare-ups and remission. In addition to its physical impact, the disease also imposes 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 Sciences entered into an agreement with Galapagos, valued at up to $2 billion, to jointly develop and commercialize filgotinib globally. However, following significant regulatory setbacks in the United States, both parties amended the filgotinib development and commercialization agreement in December 2020. Galapagos will assume responsibility for the commercialization of filgotinib in Europe (with the transition expected to be completed by the end of 2021), while Gilead Sciences will continue to commercialize filgotinib in regions outside Europe, including Japan, where it co-markets the drug with Eisai.
Currently, filgotinib is being developed for the treatment of various inflammatory diseases, with Phase 3 studies including the treatment of
Rheumatic arthritis、Crohn's disease, ulcerative colitis. However, in the field of JAK inhibitors, filgotinib also faces multiple competing products, in addition to two already marketed products
PfizerXeljanz and
Eli Lilly and CompanyBeyond Olumiant, a more formidable competitor will be AbbVie's Rinvoq (upadacitinib).
It is worth noting that,
In the first half of this year, the United StatesFDADelayed the review timeline for new indications of multiple JAK inhibitors, including Pfizer’s abrocitinib for moderate-to-severe atopic dermatitis (AD), Xeljanz/Xeljanz XR for ankylosing spondylitis (AS), and Olumiant for moderate-to-severe AD and active PsA.
The reason is that a post-marketing safety study published in January this year found that, compared with conventional older TNF inhibitors, Xeljanz increases the risk of serious cardiovascular conditions and cancer. Currently, the United States
FDAAll medications within the JAK inhibitor class are undergoing a rigorous review. The agency has requested relevant pharmaceutical companies to submit additional analytical data. (Bioon.com)
