Eli Lilly and Co said on Thursday that the U.S. health regulator had approved Omvoh, 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, Pfizer 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.
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.
Omvoh (mirikizumab-mrkz) is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of UC.
Treatment with Omvoh starts with 300-mg IV infusions, once a week every four weeks for a total of three infusions, and transitions to two, 100-mg subcutaneous self-injections every four weeks during maintenance treatment.