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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post