Janssen’s Stelara (ustekinumab) Receives the US FDA’s Approval for Moderately to Severely Active Ulcerative Colitis

Shiwani Sharma
Janssen’s Stelara (ustekinumab) Receives the US FDA’s Approval for Moderately to Severely Active Ulcerative Colitis

Shots:

  • The approval is based on P-III UNIFI studies (UNIFI-I & -M) assessing Stelara induction (6mg/kg, IV, for 8wks.) and maintenance therapy (90mg, SC, for 44wks.) vs PBO in patients with mod. to sev. UC with inadequate response to conventional therapies
  • The P-III UNIFI-I & M study results: the achievement of clinical remission (19% @ 8wks. & 45% @1yr.); @8wks. 58% of patients experience clinical response & @1yr. 43% of patients achieved clinical remission & not having steroids
  • Stelara is the first & only approved therapy for UC targeting IL-12 and IL-23 cytokines, demonstrated improvement of the colon as measured by a novel histologic-endoscopic mucosal improvement endpoint

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Forbes