Posted by Michael Wonder on 28 Jan 2020
Health Canada approves new indication for Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis
27 January 2020 - In the Phase 3 pivotal trial, nearly 44% of patients receiving Stelara subcutaneous injections every 8 weeks were in clinical remission at one year.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved Stelara (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
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 UC compared to placebo.
