Janssen’s Stelara (ustekinumab) Receives EC’s Approval for its Expanded Use to Treat Moderately to Severely Active Ulcerative Colitis

 Janssen’s Stelara (ustekinumab) Receives EC’s Approval for its Expanded Use to Treat Moderately to Severely Active Ulcerative Colitis

Janssen’s Stelara (ustekinumab) Receives EC’s Approval for its Expanded Use to Treat Moderately to Severely Active Ulcerative Colitis

Shots:

  • The EC approval is based on P-III UNIFI program [induction study (8wks. IV) & maintenance study (44wks., SC, q8w & q12w)] assessing Stelara vs PBO in patients with mod. to sev. active UC with inadequate response to conventional (corticosteroids, immunomodulators) or biologic (one or more TNF-alpha antagonists/vedolizumab) therapies
  • Induction study results: Clinical response achievement (62% vs 31%); achievement of normal stool frequency and had no bleeding. Maintenance study results: sustained effect (57.4% & 48.3% vs 35.4%) as measured by double partial Mayo remission
  • Stelara is a biologic targeting IL-12 and IL -23, approved to treat mod. to sev. plaque psoriasis in the EU. This marketing authorization follows EMA’s CHMP positive opinion received on July 25, 2019

Click here to­ read full press release/ article | Ref: Janssen | Image: Invest in Holland

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

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