Janssen’s Stelara Gets FDA Approval for Ulcerative Colitis

October 31, 2019

Janssen’s injectable drug Stelara (ustekinumab) has received the FDA’s approval for treating adults with moderately to severely active ulcerative colitis.

The new indication stems from a phase 3 clinical trial, which achieved its primary endpoint of clinical remission.

The trial results showed that treatment with Stelara both induced and maintained clinical remission in a significantly higher proportion of adult patients with the disease compared to a placebo.

View today's stories