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

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