EC Approves Second Indication for AbbVie’s SKYRIZI

AbbVie announced on Nov. 17, 2021 that the European Commission (EC) has approved SKYRIZI (risankizumab) for the treatment of active psoriatic arthritis in adults, which is the therapy’s second indication in the European Union.

The latest approval covers the use of the therapy either alone or in combination with methotrexate to treat adults with active psoriatic arthritis who have had an inadequate response or have been intolerant to one or more disease-modifying anti-rheumatic drugs. The treatment regimen approved for the second indication is 150 mg of risankizumab to be administered via subcutaneous injection at week 0, week 4, and every 12 weeks thereafter.

"People living with psoriatic arthritis struggle with psoriatic lesions and joint inflammation that causes swelling and pain. Reducing these symptoms may give people the ability to resume their daily activities and improve their quality of life," said Michael Severino, vice chairman and president, AbbVie, in a company press release. "We are excited by the EC approval of SKYRIZI for the treatment of adults with active psoriatic arthritis."

The approval for the second indication was supported by data from two Phase III studies, in which a statistical significance was achieved for the primary endpoint for efficacy and multiple secondary endpoints. Additionally, the safety profile of the therapy was consistent in psoriatic arthritis as was seen with plaque psoriasis (the initial indication for the therapy).

"Millions of people living with psoriatic arthritis are impacted by psoriatic lesions, joint pain, stiffness and fatigue," added Lars Erik Kristensen, consultant and head of science at the Parker Institute in Copenhagen Denmark, associate professor, Lund Sweden, SUS University Hospital. "As seen in this Phase [III] clinical trial program in psoriatic arthritis, SKYRIZI has the potential to be a valuable new treatment option, helping to improve the signs and symptoms of the disease."

SKYRIZI forms part of a collaboration between Boehringer Ingelheim and AbbVie, where AbbVie is responsible for leading global development and commercialization.

Source: AbbVie