Health Canada approves Skyrizi to treat Psoriatic Arthritis.
AbbVie announced Health Canada has approved Skyrizi (risankizumab), for the treatment of adult patients with active psoriatic arthritis.
In PsA, Skyrizi can be used alone or in combination with a conventional non-biologic disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate). This is the second indication for Skyrizi in Canada.
In April 2019, Health Canada approved Skyrizi for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
KEEPsAKE-1 and KEEPsAKE-2 are both Phase III, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of Skyrizi in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated Skyrizi in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated Skyrizi in patients who had an inadequate response or intolerance to biologic therapy and/or DMARD.
Related news and insights
- Deciphera Pharmaceuticals, Inc. announced that the Journal of Clinical Oncology has published results from its INTRIGUE Phase III study of Qinlock (ripretinib) in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib.
Nature Medicine has published results from a prospective, open-label, single-arm, phase II TUXEDO-1 trial of Enhertu (trastuzumab deruxtecan), from Daiichi Sankyo + AstraZeneca, which enrolled patients aged at least 18 years with HER2-positive breast cancer and newly diagnosed untreated brain metastases or brain metastases progressing after previous local therapy, previous exposure to trastuzumab and pertuzumab and no indication for immediate local therapy
Biora Therapeutics, Inc. announced topline results from its recently completed study PM 602: A Scintigraphic Study to Evaluate the Localization and Delivery Function of a Drug Delivery System Capsule (DDS) in Subjects with Ulcerative Colitis in a Fasted State