FDA approves Janssen's ulcerative colitis drug — 3 insights

The FDA expanded its approval of Janssen Pharmaceutical's ulcerative colitis drug, Stelara, for moderate and severe active ulcerative colitis.

What you should know:

1. The FDA based its approval on the company's phase 3 UNIFI clinical trial.

2. Stelara induced and maintained clinical remission in a portion of adult patients with moderate to severe ulcerative colitis. Stelara is the first and only approved biologic therapy for UC that targets the interleukin (IL)-12 and IL-23 cytokines.

3. Stelara was first approved in 2009 to treat adults with moderate to severe plaque psoriasis. It has since received four additional approvals.

For details on the phase three study, click here.

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