Posted by Michael Wonder on 19 Aug 2020
Galapagos announces that Gilead received a complete response letter for filgotinib for the treatment of moderately to severely active rheumatoid arthritis
19 August 2020 - Galapagos announces today that Gilead Sciences received a complete response letter from the U.S. FDA for the new drug application for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis.
The FDA issues complete response letters to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.
Gilead is the market authorisation holder for filgotinib in the United States and is responsible for potential commercialisation in the U.S.
