Shots:

• The application is based on 2 P-III U-ACHIEVE & U-ACCOMPLISH induction studies & 1 U-ACHIEVE maintenance study evaluating upadacitinib (45mg- qd) as IT & (15/30 mg- qd) as MT vs PBO in patients with mod. to sev. UC
• The studies met its 1EPs i.e.- patients achieved clinical remission (per Adapted Mayo Score) & 2EPs for induction (45mg) & maintenance studies (15/30 mg) @8 & 52wks. respectively. The safety results were consistent with a known safety profile of upadacitinib & no new safety risks were identified
• Rinvoq (15mg) is approved in the US for RA & in the EU for RA- PsA- AS & AD while 30mg dose is approved in the EU for AD. The P-III trials are ongoing for multiple indications

  | Ref: PR Newswire | Image: abbvie