In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended eight new medicines for approval, including an enzyme replacement therapy for a rare disease.
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Janus kinase inhibitors used for chronic inflammatory conditions are only safe for certain patients, advises the EMA’s safety committee.
AbbVie’s Rinvoq® (upadacitinib) will be available on the NHS in England and Wales for adults with active psoriatic arthritis, following NICE approval.
In the analysis, 34 percent of rheumatoid arthritis patients receiving Rinvoq® achieved Clinical Disease Activity Index (CDAI) remission.
The European Commission (EC) approved Rinvoq® as the first JAK inhibitor in Europe for the treatment of moderate to severe atopic dermatitis.
In the trial, 74 percent of participants responded to upadacitinib and 33 percent of patients achieved clinical remission.
AbbVie's RINVOQ (upadacitinib) has been approved in the EU to treat adult patients with active psoriatic arthritis (PsA).
The FDA has given its approval to RINVOQ for the treatment of active rheumatoid arthritis after the drug reached its endpoints in clinical trials.