 Home > Active Ingredient News > Immunology News > Gilead's oral JAK1 inhibitor Jyseleca has applied for a new indication in Japan: treatment of ulcerative colitis (UC)!

Gilead's oral JAK1 inhibitor Jyseleca has applied for a new indication in Japan: treatment of ulcerative colitis (UC)!

 Last Update: 2021-06-19
 Source: Internet
 Author: User

Tags

yellow number 3

jak

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

News on April 24, 2021 // --Gilead (Gilead) and Eisai (Eisai) recently announced that they have submitted an application to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan to seek approval of a new adaptation of Jyseleca (filgotinib, 200mg) for use in Treat patients with moderate to severe active ulcerative colitis (UC)
.
Currently, Jyseleca is also undergoing EU regulatory review for the treatment of new indications for UC
.

medical instruments

Jyseleca is an oral selective JAK1 inhibitor that was approved by the European Union and Japan on the same day in September 2020
.
EU, Jyseleca indications: for the treatment of one or more disease-modifying anti-rheumatic drugs (DMARD) inadequate response or intolerance to the moderate to severe category of rheumatoid arthritis (RA) in adult patients
.
In Japan, Jyseleca is indicated for the treatment of RA patients with insufficient response to conventional therapies, including the prevention of structural joint damage
.
In terms of medication, Jyseleca can be used as a monotherapy or in combination with methotrexate (MTX)
.

Rheumatoid arthritis

According to the cooperation agreement reached in December 2019, Gilead Japan holds the sales license of Jyseleca in Japan, and Eisai will be responsible for the distribution of the drug in Japan for the treatment of RA and other potential future indications, including ulcerative colon inflammation, Crohn's disease, psoriatic arthritis and the like
.

It is worth noting that in terms of US regulation, the FDA issued a complete response letter (CRL) in August 2020, refusing to approve Jyseleca
.
The FDA has requested data from the MANTA and MANTA-RAy studies
.
These two studies have now completed patient recruitment, aiming to evaluate whether filgotinib has an effect on sperm parameters.
The top-line results are expected to be announced in the first half of 2021
.
In addition, the FDA has also expressed concerns about the overall benefit/risk profile of filgotinib at a 200mg dose
.
When submitting the NDA to the FDA in December 2019 , Gilead used a Priority Review Voucher (PRV) to speed up the review
.
This PRV was bought by Gilead from Ultragenyx at a price of US$80 million
.
The CRL also means that 80 million US dollars are in vain
.

FDA

UC (Image source: healthjade.
com)

Ulcerative colitis (UC) is a long-term chronic disease affecting more than 2 million people in the European Union alone
.
Symptoms of the disease are often intermittent, so patients usually experience episodes and remissions
.

Jyseleca's application for new indications for the treatment of UC is supported by data from the Phase 2b/3 SELECTION study
.
This is a randomized, double-blind, placebo-controlled study, in 1348 patients who have not previously received biologic-naive (biologic-naive) or previously received biologic-experienced (biologic-experienced) It is carried out in adult patients with moderately to severely active UC
.

The results showed that the 200mg dose of Jyseleca met all the primary endpoints of the study, including: the proportion of patients who achieved clinical remission at week 10 and maintained clinical remission at week 58 was statistically significantly higher than the placebo group
.
In addition, the proportion of patients in the Jyseleca 200 mg dose group who obtained endoscopic, histological, and 6-month corticosteroid-free remission at 58 weeks was statistically significantly higher than that in the placebo group
.

Molecular structure of filgotinib (picture source: Wikipedia)

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 filgotinib
.
This cooperation will help to strengthen Gilead’s position in the field of inflammatory diseases, which will also become a new growth point for Gilead in the future following the hepatitis C and HIV fields
.

Currently, Gilead and the Galapagos number of studies being undertaken to assess the potential Jyseleca treat a variety of inflammatory diseases, in which the phase III studies including treatment class rheumatoid arthritis , Crohn's disease, ulcerative colitis
.
The pharmaceutical market research organization EvaluatePharma previously released a report predicting that Jyseleca will become one of Gilead’s key products to promote future growth.
Global sales in 2024 are expected to reach 1.
4 billion US dollars
.

Rheumatoid arthritis

However, in the field of JAK inhibitors, Jyseleca will also face multiple competing products.
In addition to the two listed products, Pfizer Xeljanz and Eli Lilly Olumiant, AbbVie’s Rinvoq (upadacitinib) will be the stronger opponent
.
Currently, Rinvoq has approved three indications: class rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (the AS)
.

Pfizer Eli Lilly rheumatoid arthritis

It is worth noting that just recently, the US FDA postponed the review of new indications for a number of JAK inhibitors, including Pfizer abrocitinib for the treatment of moderate to severe atopic dermatitis (AD), and Xeljanz/Xeljanz XR for the treatment of rigidity Spondylitis (AS), Olumiant treats moderate to severe AD, Rinvoq treats moderate to severe AD and active PsA
.

FDA

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
.
()

FDA

Original source: Gilead Sciences submits new drug app lication in Japan for filgotinib for the treatment of ulcerative colitis with an inadequate response to conventional therapies

app

This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.