FDA approves Janssen’s Stelara to treat Crohn’s disease

SILVER SPRING, Md. — Janssen Biotech announced Monday that the Food and Drug Administration had approved its Stelara (ustekinumab) to treat moderately to severely active Crohn’s disease.  

 

It is now indicated for adults with Crohn’s disease who have failed or were intolerant to corticosteroid or immunomodulator treatments, but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant of one or more TNF blocker treatment. 

 

“Crohn's disease is a complex condition to treat, and not all therapies work for every patient,” study investigator and chief of gastroenterology at UC San Diego School of Medicine Dr. William J. Sandborn said. “The FDA approval of Stelara represents an important advancement in treating patients with Crohn's disease, as this therapy offers an alternate mechanism of action to induce and maintain clinical remission over time. Based on the results of the clinical development program, Stelara has the potential to benefit many adults living with Crohn's disease.”