Gilead Sciences Inc. filed an application with the U.S. Food and Drug Administration seeking approval for filgotinib to treat adult patients with rheumatoid arthritis.
Rheumatoid arthritis is an autoimmune disorder characterized by the immune system mistakenly attacking healthy tissues, resulting in pain, swelling and stiffness in the joints.
The Foster City, Calif.-based drugmaker submitted a priority review voucher along with its new drug application, shortening the regulator's review time.
The application is supported by the global phase 3 Finch studies, which evaluated the medicine in a total of 3,452 patients with moderate to severely active rheumatoid arthritis. The studies met their primary goals as the medication was well tolerated and effective in treating the patients.
Gilead and Belgium's Galapagos NV are jointly developing and commercializing filgotinib under a deal signed in December 2015.
Filgotinib, which inhibits an enzyme called Janus kinase 1, is not yet approved anywhere in the world.
The European Medicines Agency is currently reviewing Gilead's marketing application for filgotinib. The company has also filed an application with the Japanese Ministry of Health, Labor and Welfare.