AbbVie (ABBV) Announces European Commission Approval of SKYRIZI

AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has approved SKYRIZI® (risankizumab, 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 anti-rheumatic drugs (DMARDs). Marking the second indication for SKYRIZI, the Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

"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, M.D., vice chairman and president, AbbVie. "We are excited by the EC approval of SKYRIZI for the treatment of adults with active psoriatic arthritis."

SKYRIZI received EC approval based on data from two Phase 3 clinical studies, KEEPsAKE-1 and KEEPsAKE-2.1-3,6 In these studies, SKYRIZI met the primary endpoint of ACR20 response at week 24 versus placebo, and ranked secondary endpoints including, but not limited to, improvements in several clinical manifestations of psoriatic arthritis such as physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) at week 24.1-3,6

Highlights from the pivotal Phase 3 program1-3,6

• In KEEPsAKE-1 and KEEPsAKE-2, 57.3 and 51.3 percent of patients receiving SKYRIZI achieved the primary endpoint of ACR20 response at week 24, respectively, versus 33.5 and 26.5 percent receiving placebo (p<0.001).
• SKYRIZI-treated patients showed significantly greater improvement from baseline in physical function as measured by HAQ-DI -0.31 and -0.22, compared to placebo -0.11 and -0.05 at week 24 (p<0.001) in KEEPSAKE-1 and KEEPSAKE-2, respectively.
• At week 24, 25.0 percent and 25.6 percent of SKYRIZI-treated patients achieved MDA, in KEEPSAKE-1 and KEEPSAKE-2 respectively, compared to 10.2 percent and 11.4 percent of those on placebo (p<0.001).

"Millions of people living with psoriatic arthritis are impacted by psoriatic lesions, joint pain, stiffness and fatigue," said Lars Erik Kristensen, M.D., Ph.D., consultant and head of science at the Parker Institute in Copenhagen Denmark, associate professor, Lund Sweden, SUS University Hospital. "As seen in this Phase 3 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."

The safety profile of SKYRIZI in psoriatic arthritis was consistent with the safety profile of SKYRIZI in plaque psoriasis, with no new safety risks observed.6 Through week 24, serious adverse events occurred in 2.5 percent and 4.0 percent of patients treated with SKYRIZI in KEEPsAKE-1 and KEEPsAKE-2, respectively, compared with 3.7 percent and 5.5 percent on placebo.1-3,6 Rates of serious infections were 1.0 and 0.9 percent in SKYRIZI-treated patients in KEEPsAKE-1 and KEEPsAKE-2, respectively, and 1.2 and 2.3 percent in patients who received placebo.1-3,6 The rates of adverse events leading to discontinuation of the study drug were 0.8 percent and 0.9 percent of patients treated with SKYRIZI in KEEPsAKE-1 and KEEPsAKE-2, respectively, compared with 0.8 percent and 2.3 percent on placebo.1-3,6 In KEEPsAKE-1, there was one death in the SKYRIZI group not related to the study drug per investigator.1,2,6 There were no deaths reported in KEEPsAKE-2.1,3,6

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

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