×
ADVERTISEMENT

OCTOBER 21, 2019

FDA Okays Stelara for UC

Label expanded to include adults with moderate, severe disease

By PPN News Staff

The FDA has approved the use of ustekinumab (Stelara, Janssen) for the treatment of moderate to severe ulcerative colitis in adults.

Ustekinumab was previously approved for a variety of rheumatologic conditions and for the treatment of moderate to severe Crohn’s disease in adults. Approval for the expanded indication was based on findings from the phase 3 UNIFI trial, which showed that the drug was more effective than placebo at inducing and maintaining clinical remission,