7 January 2019 - Janssen has submitted a Group Type II Variation Application to the EMA seeking approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis.

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 ulcerative colitis (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 mucous.

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