Filgotinib set for European approval for rheumatoid arthritis
medwireNews: The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the Janus kinase (JAK)1 -selective inhibitor filgotinib for the treatment of rheumatoid arthritis (RA).
Filgotinib will be available as 100 mg and 200 mg tablets for oral use, and is recommended for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis and an inadequate response or intolerance to at least one DMARD.
“It will be another therapeutic choice, assuming this drug becomes licensed”
This announcement follows the three phase 3 FINCH trials, which demonstrated clinical benefits of the JAK inhibitor in RA patients with and without prior exposure to methotrexate or biologic DMARDs.
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