Posted by Michael Wonder on 21 Oct 2019
Janssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis
21 October 2019 - Stelara is the first and only approved treatment for ulcerative colitis to demonstrate improvement of the colon as measured by a novel histologic-endoscopic mucosal improvement endpoint.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. FDA approval of Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis.
The approval for this new indication is based on the pivotal Phase 3 UNIFI clinical trial which achieved its primary endpoint of clinical remission. Results from UNIFI demonstrate that treatment with Stelara both induced and maintained clinical remission in a significantly greater proportion of adult patients with moderately to severely active ulcerative colitis compared to placebo.
