AbbVie (ABBV) Receives CHMP Positive Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Active Psoriatic Arthritis in the European Union

AbbVie (NYSE: ABBV) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of risankizumab (SKYRIZI®, 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). 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 3 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).1,2 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.8

"Many patients with psoriatic arthritis experience uncontrolled skin and joint symptoms despite the availability of existing therapies. For this reason, it is important to have multiple treatment options available for physicians to effectively manage their patients' condition," said Thomas Hudson, senior vice president, research and development, AbbVie. "The CHMP's recommendation to approve risankizumab in psoriatic arthritis is an important step in bringing treatment to more patients in need."

Across the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 clinical studies, risankizumab met the primary endpoint of ACR20 response at week 24 versus placebo.1,2 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.1,2

If the CHMP recommendation is accepted by the European Commission, this will mark the second indication for risankizumab in the European Union, which was approved in 2019 for the treatment of adult plaque psoriasis. The Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

Risankizumab (SKYRIZI®) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

Use of risankizumab in psoriatic arthritis is not approved and its safety and efficacy are under evaluation by regulatory authorities.

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