Janssen has submitted a Group Type II Variation Application to the European Medicines Agency (EMA) seeking approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).
The submission is based on data from the Phase III UNIFI global clinical development programme, which includes two studies (one induction and one maintenance study) evaluating the efficacy and safety of the drug for the treatment of moderately to severely active UC in adults.
A single dose of the biologic has been shown to induce clinical remission and response in patients with moderate to severe UC, a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus.
The primary endpoint of the induction study was clinical remission at week eight, as opposed to the primary endpoint for the maintenance study being clinical remission at week 44 among responders to a single intravenous (IV) Stelara infusion.
“We’re excited to bring this innovative therapy, with a proven track record in Crohn’s and other immune diseases, one step closer to being available for people living with ulcerative colitis,” said Scott Plevy, gastroenterology disease area and IL-23 pathway leader, Janssen Research & Development.
“This submission builds upon our 20-year legacy of research and development to address unmet needs of people living with inflammatory bowel diseases.”
Jannsen’s Stelara is currently approved for the treatment of moderate to severe plaque psoriasis in 90 countries, paediatric psoriasis in 43 countries, psoriatic arthritis in 83 countries and Crohn’s disease in 62 countries.