medwireNews: The EMA’s Committee for Medicinal Products for Human Use has expanded the indication of subcutaneous infliximab to include psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
Previously only approved for rheumatoid arthritis in Europe, the subcutaneous formulation of the tumor necrosis factor (TNF) inhibitor may now also be given to certain adult patients with PsA, AS, psoriasis, and inflammatory bowel disease, in line with the adult indications of the intravenous formulation.
For PsA, the EMA specifies that subcutaneous infliximab is indicated for patients with active and progressive disease despite previous DMARD therapy, and should be given in combination with methotrexate unless contraindicated.
And for AS, the TNF inhibitor is approved for patients with severe, active disease and an inadequate response to conventional therapy.
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