September 23, 2023

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Gilead-Galapagos oral JAK1 inhibitor Jyseleca for UC will be approved in EU

Gilead-Galapagos oral JAK1 inhibitor Jyseleca for ulcerative colitis (UC) will be approved in EU

Gilead-Galapagos oral JAK1 inhibitor Jyseleca for UC will be approved in EU.

New drug for ulcerative colitis (UC)! Gilead-Galapagos oral JAK1 inhibitor Jyseleca will soon be approved in the EU: improve symptoms and lasting relief!

Jyseleca has been approved to treat rheumatoid arthritis (RA) in the European Union and Japan.

Gilead-Galapagos oral JAK1 inhibitor Jyseleca for UC will be approved in EU
Ulcerative colitis (UC, image source:

Galapagos NV, a partner of Gilead Sciences, recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review suggesting the approval of the oral anti-inflammatory drug Jyseleca (filgotinib, filgotinib). Ni, 200mg), this drug is a JAK1 priority inhibitor taken orally once a day for the treatment of moderate to severe active ulcerative colitis ( UC) Adult patients.

Now, CHMP’s opinions will be submitted to the European Commission (EC) for review, which usually makes a final review decision within 2 months.

If approved, Jyseleca will provide a new treatment option for patients with moderate to severe active UC in the European Union. It is worth noting that the US FDA has not approved any indication for Jyseleca due to safety considerations.

Jyseleca is an oral selective JAK1 inhibitor that has been approved for marketing in the European Union, the United Kingdom, and Japan for the treatment of moderate to severe patients with insufficient or intolerance to one or more disease-modifying anti-rheumatic drugs (DMARD) Adult patients with rheumatoid arthritis (RA).

In terms of medication, Jyseleca can be used as a monotherapy or in combination with methotrexate (MTX). At present, Jyseleca’s application for the treatment of UC indications is also undergoing regulatory review in the United Kingdom and Japan.

It is worth mentioning that just recently, AbbVie submitted a new indication application for oral JAK1 inhibitor Rinvoq (upadacitinib, upatinib) to the US FDA and EU EMA: for the treatment of moderate to severely active UC Adult patients. Rinvoq is also an oral selective JAK1 inhibitor.

CHMP’s positive opinions are based on data from the critical 2b/3 SELECTION project. This project evaluated the efficacy and safety of Jyseleca as an induction and maintenance therapy in moderately to severely active UC adult patients who have failed conventional therapies or biologics.

SELECTION includes 2 placebo-controlled induction studies, one for patients who have been biologic-naive (biologic-naive, not previously received biologics), and the other for biologic-experienced (biologic-experienced, previously received biologics) patients Patients, and then a 47-week maintenance study for patients who responded to Jyseleca after 10 weeks of treatment. Placebo responders continued to use blind placebo during the maintenance period.

The results of the SELECTION trial were recently published in The Lancet, see: Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial.

Gilead-Galapagos oral JAK1 inhibitor Jyseleca for UC will be approved in EU

Molecular structure of filgotinib (picture source: Wikipedia)

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD). The symptoms of the disease are often intermittent, so patients usually experience attacks and remissions. In addition to the physical effects, the disease can also bring significant psychological effects.

The active pharmaceutical ingredient of Jyseleca is filgotinib, which is a highly selective JAK1 inhibitor discovered and developed by Galapagos.

At the end of December 2015, Gilead reached an agreement with Galapagos for a total amount of up to 2 billion U.S. dollars to jointly develop and commercialize filgotinib globally.

However, due to major setbacks in US regulation, the two parties revised the commercialization and development agreement of filgotinib in December 2020.

Galapagos will be responsible for the commercialization of filgotinib in Europe (the transition period is expected to be completed at the end of 2021), while Gilead will continue to be responsible for filgotinib outside Europe, including Japan (where Gilead will jointly sell filgotinib with Eisai).

Currently, filgotinib is being developed to treat a variety of inflammatory diseases, of which Phase 3 studies include the treatment of rheumatoid arthritis, Crohn’s disease, and ulcerative colitis.

However, in the field of JAK inhibitors, filgotinib also faces multiple competing products. In addition to the two listed products, Pfizer Xeljanz and Eli Lilly Olumiant, the stronger opponent will be AbbVie’s Rinvoq (upadacitinib).

It is worth noting that in the first half of this year, the US FDA postponed the review timetable for new indications of a number of JAK inhibitors, including Pfizer abrocitinib for the treatment of moderate to severe atopic dermatitis (AD), Xeljanz/Xeljanz XR treats ankylosing spondylitis (AS), Olumiant treats moderate to severe AD, Rinvoq treats moderate to severe AD and active PsA.

The reason is that, in a post-marketing safety study published in January this year, it was found that Xeljanz would increase the risk of serious heart-related diseases and cancer compared with traditional TNF inhibitors.

Currently, the US FDA is rigorously reviewing all drugs in the JAK inhibitor category. The agency has asked relevant pharmaceutical companies to provide additional analysis data.

(source:internet, reference only)

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