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20-10-2021 | Rheumatology | News | Article

approvalsWatch

EMA recommends expanding risankizumab indication to include PsA

Author: Shreeya Nanda

medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended that the indication for the interleukin (IL)-23 inhibitor risankizumab be extended to include psoriatic arthritis (PsA).

Previously authorized in Europe for plaque psoriasis, risankizumab – either given alone or alongside methotrexate – is now also indicated for the treatment of active disease in people with an inadequate response or intolerance to at least one DMARD.

The clinical benefit of the IL-23 inhibitor was demonstrated in the KEEPsAKE 2 trial, in which response rates were significantly higher with risankizumab than placebo in patients who had an inadequate response to either conventional or biologic DMARDs.

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