![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Gilead Sciences’ Jyseleca Approved in Japan for Rheumatoid Arthritis
Gilead Sciences’ Jyseleca Approved in Japan for Rheumatoid Arthritis
September 28, 2020
Japan’s Ministry of Health, Labor and Welfare has approved Gilead Sciences’ Jyseleca (filgotinib 200 mg and 100 mg tablets) to treat rheumatoid arthritis in patients who have had inadequate response to conventional therapies.
The approval was based on phase 2 and 3 clinical trials in which patients receiving the drug once daily showed improvements in clinical symptoms, decreases in disease activity and less progression of structural damage in their joints.
Gilead will work with Eisai to commercialize the product in Japan.
Upcoming Events
-
21Oct