EU Approves Gilead/Galapagos' Oral JAK1 Inhibitor Jyseleca for New Indication in Ulcerative Colitis

November 17, 2021 /BioValleyBIOON/ -- Gilead Sciences' partner Galapagos NV recently announced that the European Commission (EC) has approvedOral Anti-Inflammatory Drug Jyseleca (Filgotinib, 200mg Tablets)A new indication,This medicine is a once-daily oral JAK1 preferential inhibitor., for the treatment of moderate to severe active disease with inadequate response, loss of response, or intolerance to conventional therapy or biologicsUlcerative Colitis (UC)Adult patients. With the approval of the new indication, 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 StatesFDANo indications for Jyseleca have been approved yet.

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 patients with inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).Moderate to Severe ClassRheumatoid Arthritis(RA) Adult PatientsIn terms of medication, Jyseleca can be used as a monotherapy or in combination with methotrexate (MTX). Currently, the application for the UC indication of Jyseleca is also under regulatory review in the UK and Japan.

Notably, in September this year, 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.

This new indication approval is based on data from the pivotal Phase 2b/3 SELECTION program. The 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 an inadequate response to or had failed conventional or biologic therapies. SELECTION included two placebo-controlled induction studies, one in biologic-naive patients (those who had not previously received biologics) and another in biologic-experienced patients (those who had previously received biologics), followed by a 47-week maintenance study for patients who responded to Jyseleca at week 10. Placebo responders continued on blinded placebo during the maintenance period. Results from the SELECTION trial were recently published in The Lancet. For more 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), with symptoms that are often intermittent, meaning patients typically 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 Sciences entered into an agreement worth up to $2 billion with Galapagos 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 the commercialization of filgotinib in Europe (with the transition expected to be completed 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 multiple competing products, aside from the two already marketed products.PfizerXeljanz andEli LillyAside from Olumiant, the stronger competitor will be AbbVie's Rinvoq (upadacitinib).

It is worth noting that,In the first half of this year, the United StatesFDADelayed the review schedule for new indications of multiple JAK inhibitors, including Pfizer's abrocitinib (Abrocitinib) for the treatment of moderate to severe atopic dermatitis (AD), Xeljanz/Xeljanz XR for the treatment of ankylosing spondylitis (AS), Olumiant for the treatment of moderate to severe AD, Rinvoq for the treatment of 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 traditional TNF inhibitor older drugs, Xeljanz increases the risk of serious heart-related diseases and cancer. Currently, the United StatesFDAA strict review of all drugs in the JAK inhibitor category is currently underway. The agency has requested relevant pharmaceutical companies to provide additional analytical data. (Bioon.com)

Source of Original Text:Jyseleca®▼(filgotinib) approved in the European Union for the treatment of ulcerative colitis