Eli Lilly on Thursday announced that its experimental drug met the main goals of a late-stage study to test it as a treatment for moderately to severely active Crohn’s disease.
It is a chronic bowel disease that causes inflammation in the digestive tract, and can lead to diarrhea, abdominal pain, fatigue and weight loss.
Treatment with the drug, mirikizumab, helped 54.1 per cent patients to achieve a state where they were no longer experiencing any gastrointestinal symptoms, after 52 weeks, compared with 19.6% who received placebo.
According to a report by news agency Reuters, the drug was also shown not to be inferior to Johnson & Johnson’s Stelara in helping symptoms of the disease disappear.
Lilly said the frequency of serious adverse events was greater in placebo than with patients dosed with mirikizumab.
In April, the U.S. Food and Drug Administration (FDA) had declined to approve the use of the drug in adults with ulcerative colitis, a type of chronic inflammatory bowel disease. The health agency cited issues related to the proposed manufacturing of mirikizumab and did not raise any issues with the clinical data or safety of the drug at the time.
The drug is among Lilly’s potential growth drivers for this decade alongside tirzepatide for obesity, lebrikizumab for atopic dermatitis or eczema and pirtobrutinib for cancer.
Reportedly, Lilly said it plans to submit data from the late-stage study in 2024 to the FDA, as well as other global health regulators.
(With inputs from Reuters)
