FDA rejects New Drug Application for filgotinib for treatment of moderately to severely active rheumatoid arthritis

The Agency requested data from MANTA and MANTA-Ray trials of this JAK inhibitor before completing its review. Both studies were designed to evaluate whether filgotinib had impact on sperm parameters. There are also concerns over overall benefit/risk profile of 200 mg dose.

SPS commentary:

The MANTA and MANTA-Ray trials are ongoing, fully recruited, and topline data are expected in the first half of 2021.


Filgotinib was recommended for approval in EU by CHMP in July 2020 for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs.


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