AbbVie Submits Regulatory Applications to the US FDA and EMA for Rinvoq (upadacitinib) to Treat Active Ulcerative Colitis

September 17, 2021 Auto Bot regulatory 0

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

Click here to­ read full press release/ article | Ref: PR Newswire | Image: Fierce Biotech

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