"We remain confident in mirikizumab's pivotal Phase 3 clinical data and its potential to help people with ulcerative colitis," said Patrik Jonsson, Lilly executive vice president, president of Lilly Immunology and Lilly USA, and chief customer officer. "We are working diligently with the FDA and hope to launch mirikizumab in the U.S. as soon as possible."

Lilly recently received approval for mirikizumab as a first-in-class treatment for adults with moderately to severely active UC in Japan. In addition, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for mirikizumab as a first-in-class treatment for adults with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment. Regulatory decisions are anticipated in additional markets around the world in 2023.