Gilead Reports Submission of Filgotinib’s NDA Under Priority Review to the US FDA for Rheumatoid Arthritis Treatment
Gilead Signs an Exclusive Worldwide License Agreement with Novartis for its Three Preclinical Antiviral Programs
Shots:
- The filling of NDA is based on P-III FINCH clinical program assessing Filgotinib in 3,452 patients with moderate to severely active RA in people with prior inadequate response to MTX, those who were intolerant to one or more biologic treatments and those who were MTX treatment-naïve
- The study demonstrated meeting all 1EPs with durable efficacy and safety results in patients with RA and resulted in consistent safety and tolerability profile
- Filgotinib is an oral, selective JAK1 inhibitor targeted for the treatment of adults with moderate-to-severe RA and is the third regulatory submission in the past 5 mos. post-EMA, JMLW in H1’19
Click here to read full press release/article | Ref: Gilead | Image: Twitter