(RTTNews) - Gilead Sciences, Inc. (GILD) has submitted a New Drug Application for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults with rheumatoid arthritis, to the Japanese Ministry of Health, Labor and Welfare. The NDA is supported by data from the Phase 3 FINCH clinical trial program.
"This new drug application is an important milestone as we continue to expand Gilead's presence in Japan to now also include inflammation," said Luc Hermans, President and Representative Director, Gilead Sciences, K.K.
Filgotinib is an investigational agent and is not approved anywhere globally.
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