After the FDA passed on an approval for mirikizumab in ulcerative colitis earlier this year because of manufacturing shortfalls, the Eli Lilly drug is gaining new momentum with a win in a phase 3 Crohn’s disease study.
The interleukin-23p19 antagonist achieved both primary endpoints and all of its major secondary endpoints in the VIVID-1 study, Lilly said in a Thursday release. The trial results will serve as the basis of regulatory submissions in the disease next year, the company added.
In the study, Lilly's drug helped 54.1% of participants achieve clinical remission at week 52, compared with 19.6% for those on placebo.
However, the drug couldn’t prove superiority in the endoscopic response measure when pitted against Johnson & Johnson’s star immunosuppressant Stelara (ustekinumab). Still, mirikizumab's results were “numerically higher” than its J&J counterpart, Lilly said.
Lilly will pursue approval in Crohn’s in 2024, when it will submit a marketing application to the FDA and other regulatory agencies.
While the med is cleared for ulcerative colitis in the U.K., Japan, Germany and Canada, the company is looking for a U.S. comeback after its April rejection.
The FDA declined the med's approval after finding manufacturing issues at a pre-approval inspection. At the time, a Lilly spokesperson said that the company was discussing next steps with the agency to understand the time needed to resolve its concerns.