Stelara filed with EMA for ulcerative colitis.- Janssen.
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.
Comment: Stelara was filed with the FDA for ulcerative colitis in December 2018.
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