AbbVie (NYSE:ABBV) announced that the interleukin-23 antagonist Skyrizi (risankizumab) had received backing from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to treat active psoriatic arthritis.
The committee recommended the drug for adults with active psoriatic arthritis who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs.
CHMP recommended an initial 150-mg of subcutaneous injection of Skyrizi followed by subsequent doses at four weeks and then every 12 weeks after that.
In the U.S., the drug is indicated for certain adults with moderate-to-severe plaque psoriasis. FDA approved the drug in 2019.
In April, North Chicago–based AbbVie announced that it had submitted paperwork to the FDA for the indication of psoriatic arthritis.
Approval for psoriatic arthritis in Europe and the U.S. would elevate AbbVie’s stature in that treatment space, where it already has a strong presence given the popularity of the Humira (adalimumab), which brought in almost $20 billion in revenue last year.
The CHMP positive opinion for Skyrizi was based on data from the KEEPsAKE-1 and KEEPsAKE-2 Phase 3 trials. The drug met the primary and ranked secondary endpoints in both studies.
Filed Under: Rheumatology