Lilly's bowel disease drug gets US FDA nod for treatment in adults

[October 27, 2023]  (Reuters) -Eli Lilly and Co said on Thursday that the U.S. health regulator had approved its drug for treating adults with moderate-to-severe active ulcerative colitis, a type of chronic inflammatory bowel disease.

The drug, which will be available in the United States in coming weeks and sold under brand name Omvoh, is among Lilly's potential growth drivers for this decade alongside tirzepatide for obesity, lebrikizumab for atopic dermatitis or eczema and pirtobrutinib for cancer.

The agency's decision will help Lilly enter a sector, where drugs from rivals such as Abbvie Inc, Pfizer Inc and Johnson & Johnson are already jostling for a share of the multi-billion dollar market.

The approval was based on data from late-stage studies of the drug that showed it helped improve the symptoms of the disease compared with placebo.

The latest approval comes after a setback in April, when The U.S. Food and Drug Administration (FDA) had declined clearance citing issues related to the proposed manufacturing of the treatment.

An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021. Picture taken March 5, 2021. REUTERS/Mike Segar/File Photo

Lilly has received approval for the drug in Japan and the European Union this year.

Ulcerative colitis is a condition where abnormal reactions of the immune system cause inflammation and ulcers on the inner lining of the colon, possibly leading to diarrhea, passing of blood with stool and abdominal pain.

Shares of the company were up about 0.5% in extended trading on Thursday.

(Reporting by Pratik Jain and Khushi Mandowara in Benagluru; Editing by Anil D'Silva)

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