Johnson & Johnson obtains FDA OK for new indication for Tremfya

The Food and Drug Administration has approved Johnson & Johnson’s Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis, a chronic disease of the large intestine in which the lining of the colon becomes inflamed. 

Tremfya is now approved for the treatment of plaque psoriasis, active psoriatic arthritis and ulcerative colitis.

"Treatment with Tremfya resulted in significant improvement in the chronic symptoms of ulcerative colitis, and importantly, normalization in the endoscopic appearance of the intestinal lining," said David Rubin, director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, and lead investigator for the QUASAR program. "Today's approval of Tremfya builds on the clinical and well-established safety profile of this IL-23 inhibitor and marks a significant step forward in the treatment of this chronic inflammatory disease."

[Read more: Sandoz obtains FDA nod for Stelara biosimilar]

"There is a significant need for new UC therapies that offer meaningful improvements in symptoms and the promise of remission, both overall clinical remission as well as delivering visible healing of the colon through endoscopic remission," said Christopher Gasink, vice president of medical affairs, gastroenterology and autoantibody at Johnson & Johnson Innovative Medicine. "In the QUASAR clinical program, Tremfya demonstrated high reported rates of endoscopic remission at one year of treatment, continuing to raise the bar for efficacy in the treatment of this inflammatory bowel disease."

[Read more: AbbVie receives FDA nod for new indication of Skyrizi]