AbbVie receives CHMP positive opinion for Skyrizi for the treatment of adults with active psoriatic arthritis in the European Union.
The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union.
This CHMP positive opinion was supported by data from two pivotal Phase III studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated risankizumab in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying antirheumatic drugs (DMARDs). Additionally, the efficacy and safety profile of risankizumab with up to 52 weeks of exposure was consistent with the profile observed up to 24 weeks.
Across the Phase III KEEPsAKE-1 and KEEPsAKE-2 clinical studies, risankizumab met the primary endpoint of ACR20 response at week 24 versus placebo. In both studies, risankizumab also met ranked secondary endpoints including, but not limited to improvements in several clinical manifestations of psoriatic arthritis such as skin clearance (as measured by at least a 90 percent improvement in Psoriasis Area Severity Index [PASI 90]), physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) at week 24. In both KEEPsAKE-1 and KEEPsAKE-2, the most common adverse reactions associated with risankizumab were upper respiratory infections, headache, fatigue, injection site reactions and tinea infections.
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