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Janssen (J&J) Reports Filing of Stelara's (ustekinumab) in Group Type II Variation Application to EMA for Moderately to Severely Active Ulcerative Colitis (UC)

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Janssen (J&J) Reports Filing of Stelara's (ustekinumab) in Group Type II Variation Application to EMA for Moderately to Severely Active Ulcerative Colitis (UC)

Janssen (J&J) Reports Filing of Stelara's (ustekinumab) in Group Type II Variation Application to EMA for Moderately to Severely Active Ulcerative Colitis (UC)

Shots:

  • The submission is based on P-III UNIFI study (had two part one induction and second maintenance) results assessing Stelara vs PBO (130 mg- 6 mg/kg) in 961 patients in ratio (1:1:1) with moderately to severely active UC for a duration of 1 year
  •  P-III UNIFI study results: clinical remission (15.6%- 15.5% vs 15.3%); endoscopic healing (26.3%- 27.0% vs 5.3%); clinical response (51.3%- 61.8% vs 31.3%); mucosal healing (20.3%- 18.4% vs 8.9%); IBDQ improvements (31.5-31.0 vs 10)- also presented at ACG & UEGW in 2018
  • Stelara (ustekinumab) is a mAb developed for targeting IL-12 and IL-23 cytokines indicated for plaque psoriasis and psoriatic arthritis. Additionally- the submission involves Stelara’s sBLA filling to FDA for moderately to severely active UC in adults on 20 dec- 2018

Ref: J&J | Image: Janssen


Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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