AbbVie Submits Application to the EMA for Skyrizi (risankizumab) to Treat Crohn's Disease
Shots:
- The application is based on the 3 P-III studies i.e., (ADVANCE), (MOTIVATE) & (FORTIFY) to evaluate risankizumab as induction & maintenance therapy in adults aged ≥16yrs. with CD with inadequate response or were intolerant to conventional or biological therapy
- In all studies, patients treated with risankizumab (600mg, IV) induction therapy & 360mg, SC as maintenance therapy achieved both 1EPs & improvements in clinical remission & endoscopic response @12wks. over PBO & @52wks. compared to those who were withdrawn from risankizumab
- Additionally, no new safety risks were identified compared to the known safety profile. If approved, risankizumab marks the 3rd indication for CD in the EU
/ article | Ref: AbbVie | Image:abbvie
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