Eli Lilly has reported positive results for its experimental drug mirikizumab in a late-stage study for the treatment of moderately to severely active Crohn’s disease. Crohn’s disease is a chronic bowel condition that causes inflammation in the digestive tract, leading to symptoms such as diarrhea, abdominal pain, fatigue, and weight loss. The study showed that treatment with mirikizumab helped 54.1% of patients achieve a state where they were no longer experiencing any gastrointestinal symptoms after 52 weeks, compared to 19.6% in the placebo group. The drug also demonstrated non-inferiority to Johnson & Johnson’s Stelara in alleviating symptoms of the disease.
The U.S. Food and Drug Administration (FDA) had previously declined to approve mirikizumab for use in adults with ulcerative colitis, another type of chronic inflammatory bowel disease. The FDA cited issues related to the proposed manufacturing of mirikizumab but did not raise concerns about the drug’s clinical data or safety. Eli Lilly plans to submit data from the recent late-stage study to the FDA and other global health regulators in 2024.
Mirikizumab is among Eli Lilly’s potential growth drivers for the coming decade, along with other drugs such as tirzepatide for obesity, lebrikizumab for atopic dermatitis or eczema, and pirtobrutinib for cancer. The positive results in the Crohn’s disease study represent a significant development for the drug. If approved, it could provide a new treatment option for patients with this challenging condition.
The drug’s efficacy in helping patients achieve relief from gastrointestinal symptoms is a promising outcome, and Eli Lilly’s submission of data to regulatory authorities reflects its commitment to advancing the drug’s development. Crohn’s disease is a serious condition with a significant impact on patient’s quality of life, and new therapeutic options are essential for improving outcomes in affected individuals.