According to a report by Reuters, Eli Lilly and Co on Thursday announced that the U.S. health regulator had granted approval for its drug designed to treat adults with moderate-to-severe active ulcerative colitis, a form of chronic inflammatory bowel disease.
The drug, which will soon be available in the United States under the brand name Omvoh, is part of Lilly's growth initiatives for the current decade, alongside medications like tirzepatide for obesity, lebrikizumab for atopic dermatitis or eczema, and pirtobrutinib for cancer, the report informed.
Reportedly, the approval of Omvoh by the FDA was primarily grounded in the favourable results of late-stage trials, demonstrating the drug's effectiveness in alleviating disease symptoms in comparison to a placebo.
It's noteworthy that this approval comes on the heels of a setback in April when the U.S. Food and Drug Administration (FDA) initially declined to grant clearance due to concerns related to the drug's proposed manufacturing process. Nevertheless, Eli Lilly achieved regulatory approval for the drug in Japan and the European Union earlier this year, the report from Reuters stated.
Ulcerative colitis, a condition marked by abnormal immune system responses leading to inflammation and ulcers in the inner lining of the colon, often manifests through symptoms like diarrhoea, rectal bleeding, and abdominal pain.
After the announcement, shares of the company rose approximately 0.5 per cent during extended trading on Thursday.
(Reuters)