Express . . . For the treatment of rheumatoid arthritis, Gilead used priority review vouchers to submit a new jak1 inhibitor application.

▎ yaomingkant / report today, Gilead Sciences announced that it has submitted a new drug application (NDA) for Jak1 inhibitor filgtinib to the U.S. FDA for the treatment of adult patients with moderate to severe rheumatoid arthritis.filgotinib is one of the key R & D projects of Gilead Science in the field of inflammatory diseases.at the same time of submitting NDA, the company has used the priority review voucher, which will shorten the review time of FDA, and show Gilead's determination to bring this innovative therapy to the market as soon as possible.rheumatoid arthritis (RA) is a chronic inflammatory disease, which may affect the function of multiple joints.this is an autoimmune disease in which the immune system attacks the synovium in its own joints, causing inflammation and thickening of the synovium, which eventually damages cartilage and bone in the joint.rheumatoid arthritis affects the lives of 23.7 million people worldwide.methotrexate (MTX) is usually the first-line treatment for this disease. However, many patients are intolerant of MTX or have adverse reactions. They need new treatment methods to alleviate the disease progression.filgtinib is a selective inhibitor of Jak1 developed by Gilead science and Galapagos.JAK kinase dependent cytokines are associated with the pathogenesis of many inflammatory and autoimmune diseases.this property indicates that JAK inhibitors can be used to treat a variety of inflammatory diseases, including rheumatoid arthritis.this application is supported by data obtained from the global phase 3 clinical development project called finch.for example, in a randomized, double-blind finch 1 trial with placebo and active control, patients who had received MTX treatment but had adverse reactions received filgtinib, placebo or adalimumab.all patients continued to receive MTX treatment at the same time.the results showed that, after 12 weeks, the proportion of patients who achieved ACR20 (one of the American Society of Rheumatology therapy evaluation indicators) in filgtinib group was significantly higher than that in placebo group, reaching the main end point of the trial.} summary of finch 1 clinical trial efficacy data (photo source: reference [2]). In the finch 3 clinical trial, filgtinib was used as a monotherapy or combined with MTX to treat RA patients without MTX treatment.the results showed that the combination of filgtinib and MTX significantly increased the proportion of patients reaching ACR20 compared with MTX after 24 weeks of treatment.combination therapy also achieved a number of key secondary endpoints. } finch 3 clinical trial efficacy data summary (photo source: reference [2]) "this new drug application represents an important step in the process of bringing this innovative treatment option to patients with rheumatoid arthritis," merdad, chief medical officer, Gilead sciences "Filgtinib has shown good efficacy and tolerability in clinical trials and can provide a meaningful improvement in patients with rheumatoid disease," said Dr. parsey. "reference: [1] Gilead submit filgtinib new drug application to U.S. Food and drug administration under priority review for rheumatoid arthritis treatment. Retrieved December 19, 2019, from Gilead and Galapagos announcement filiginib meets primary and key secondary endpoints in the phase 3 finance 1 rheumatoid arthritis study Retrieved March 29, 2019, from