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Skyrizi receives AIFA reimbursement for ulcerative colitis in Italy
The Italian Medicines Agency (AIFA) has approved the reimbursement of risankizumab (Skyrizi) for the treatment of adult patients with moderate to severe active ulcerative colitis. This approval applies to patients who have demonstrated an inadequate response, loss of response, or intolerance to conventional or biological therapies.
Separately, AbbVie has submitted an application to the European Medicines Agency (EMA) seeking approval for the subcutaneous induction of Skyrizi for adult patients with moderately to severely active Crohn's disease. This submission is supported by positive data from the Phase 3 AFFIRM study. If approved, patients would have the option to receive induction doses via subcutaneous injection followed by subcutaneous maintenance doses every eight weeks.
Entities
AIFA · AbbVie · European Medicines Agency · Italy · Skyrizi
Claims
What the coverage asserts, and how many sources carry each claim.
- [○ 1 SOURCE] AbbVie has submitted an application to the European Medicines Agency (EMA) for subcutaneous induction of Skyrizi for Crohn's disease. www.stocktitan.net
- [● 2 SOURCES] The treatment is for patients who showed inadequate response, loss of response, or intolerance to conventional or biological therapies. www.farmacista33.it · www.unmondoditaliani.com
- [● 2 SOURCES] The Italian Medicines Agency (AIFA) has approved reimbursement for risankizumab (Skyrizi) in Italy. www.farmacista33.it · www.unmondoditaliani.com
- [○ 1 SOURCE] The EMA application is supported by positive data from the Phase 3 AFFIRM study. www.stocktitan.net
- [● 2 SOURCES] Risankizumab is approved for adult patients with moderate to severe active ulcerative colitis. www.farmacista33.it · www.unmondoditaliani.com