AbbVie (NYSE:ABBV) announced today that a European governing body recommended approval for its psoriatic arthritis treatment injection.
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).
Chicago-based AbbVie said in a news release that the positive CHMP opinion came on the back of data from two pivotal Phase 3 studies evaluating risankizumab, both of which reached the primary endpoint of ACR20 response at week 24 versus placebo.
The most common adverse reactions associated with the treatment were upper respiratory infections, headache, fatigue, injection site reactions and tinea infections.
Should the CHMP recommendation be accepted by the European Commission, it would mark risankizumab’s second indication in Europe after the drug received approval in 2019 for the treatment of adult plaque psoriasis. The drug is a product of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading global development and commercialization efforts.
“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,”AbbVie SVP of R&D Thomas Hudson said in a news release. “The CHMP’s recommendation to approve risankizumab in psoriatic arthritis is an important step in bringing treatment to more patients in need.”