Stelara FDA approval for ulcerative colitis treatment : The Janssen Pharmaceutical Companies of Johnson & Johnson has bagged approval from the US Food and Drug Administration (FDA) for Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis.
Considered to be a serious, chronic and progressive immune-mediated inflammatory disease of the large intestine, ulcerative colitis affects nearly 910,000 people in the US.
Stelara is now the first and only approved biologic therapy for ulcerative colitis that targets the interleukin (IL)-12 and IL-23 cytokines, which are known to play a major role in inflammatory and immune responses.
Originally approved by the FDA in September 2009 for the treatment of adults with moderate to severe plaque psoriasis, Stelara had also been approved for moderate to severe plaque psoriasis in adolescent patients, active psoriatic arthritis in adults, and moderately to severely active Crohn’s disease (CD) in adults.
Stelara FDA approval for ulcerative colitis treatment in adult patients has been driven by the findings of the phase 3 UNIFI clinical trial which met its primary endpoint of clinical remission.
Results from the UNIFI clinical trial showed that treatment with Stelara triggered and also sustained clinical remission in a significantly larger proportion of adults having moderately to severely active ulcerative colitis, in comparison to placebo.
According to Janssen, Stelara is the first and only approved ulcerative colitis treatment to offer improvement of the intestinal lining as assessed by a histologic-endoscopic mucosal improvement endpoint.
Commenting on Stelara FDA approval as a new ulcerative colitis treatment, David M. Lee – Immunology Therapeutic Area Head at Janssen Research & Development, said: “At Janssen, we have a longstanding commitment to developing innovative new options that can help address the unmet treatment needs for those living with immune-mediated diseases.
“With today’s milestone, Stelara has received its fifth FDA approval since 2009, a testament to our unwavering focus on delivering treatments for patients who have limited therapeutic options.”
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