Posted by Michael Wonder on 16 Dec 2020
Gilead and Galapagos announce new commercialisation and development agreement for Jyseleca (filgotinib)
15 December 2020 - Gilead will not advance Jyseleca for the treatment of rheumatoid arthritis in the U.S. following FDA Type A meeting.
Based on the feedback received from the FDA during the NDA review process and in the Type A meeting, Gilead will not pursue FDA approval of filgotinib for patients with rheumatoid arthritis. While both Gilead and Galapagos continue to believe in the clinical profile of the 200 mg dose, Gilead has concluded that this dose is required to be competitive in rheumatoid arthritis in the United States and that the 200 mg dose is unlikely to achieve approval for rheumatoid arthritis in the U.S. without conducting substantial additional clinical studies.
