Astellas' JAK3 Inhibitor Peficitinib Approved in China for Rheumatoid Arthritis
Astellas
Pharmaceutical R&D Manufacturer
On August 5, according to the NMPA official website, Astellas' JAK3 inhibitor Peficitinib for the treatment of rheumatoid arthritis has been approved for marketing.Acceptance Number:JXHS2200073）。
Screenshot from: NMPA official website
Peficitinib is a selective JAK3 inhibitor independently developed by Astellas. It was first approved for marketing in Japan in March 2019, with the approved indication being rheumatoid arthritis that has shown an inadequate response to conventional therapies.Including the prevention of structural joint damage) Patient.
In an interim analysis of an open-label, multicenter extension study of rheumatoid arthritis patients who completed the Phase 2b and Phase 3 peficitinib studies, eligible patients (n = 843) Take orally once daily, Ixazomib (100 mg or 50 mg). The dose of Pexidartinib can be increased at the discretion of the investigator (Up to 150 mg) or decrease (To 50 mg）。
The results showed that, as of May 2018, the average exposure time to pexidartinib was 22.7 months, with the majority (66.5%) The maximum dose for patients is 100 mg. During the extension study, ACR responses were maintained, with ACR20/50/70 response rates at Week 0 being 71.6%, 52.1%, and 34.7%, respectively, and at the end of treatment being 78.9%, 61.4%, and 42.7%, respectively. The study confirmed that the efficacy of peficitinib was maintained or improved during long-term use and was well-tolerated in Asian patients with rheumatoid arthritis over up to 6 years of treatment.
Screenshot from: insight database official website
Cover Source:Corporate Logo
Disclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It also does not recommend or introduce any treatment plans. If you have any needs, please consult and contact正规医疗机构.
PR Article Coordination: WeChat insightxb
SubmissionWeChat: insightxb; Email: insight@dxy.cn
