Lilly’s Omvoh shows sustained 4-year efficacy in ulcerative colitis

INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY), a pharmaceutical giant with a market capitalization of $758 billion and "GREAT" financial health according to InvestingPro, announced Tuesday that its ulcerative colitis treatment Omvoh (mirikizumab-mrkz) demonstrated sustained efficacy over four years of treatment, according to final results from the LUCENT-3 Phase 3 open-label extension study.

The data showed that approximately 80% of patients who achieved clinical remission at one year maintained long-term, corticosteroid-free clinical and endoscopic remission through four years of treatment. Additionally, 93% of these patients experienced significant improvement in bowel urgency, one of the most disruptive symptoms for ulcerative colitis patients. This development comes as Eli Lilly maintains strong operational performance, with a remarkable 36.83% revenue growth and industry-leading 82.64% gross profit margin in the last twelve months.

Among patients who achieved clinical remission with Omvoh at one year in the LUCENT-2 study, 78% maintained corticosteroid-free clinical remission and endoscopic remission after four years of total treatment. The study also found that 66% achieved histological-endoscopic mucosal improvement.

The long-term safety profile remained consistent with Omvoh’s known safety profile, with no new safety signals observed. Of patients who completed one year of blinded maintenance therapy and continued to LUCENT-3, 12% reported a serious adverse event, while 7% discontinued treatment due to an adverse event.

"These long-term findings reinforce mirikizumab as a highly effective biologic for UC management," said Bruce Sands, Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at Icahn School of Medicine at Mount Sinai, according to the company’s press release.

Omvoh, an interleukin-23p19 antagonist, has received regulatory approvals for the treatment of moderately to severely active ulcerative colitis and Crohn’s disease in adults and has been approved in 44 countries worldwide.

Lilly is advancing additional studies of mirikizumab, including combination studies with other treatments aimed at delivering improved efficacy while maintaining long-term remission and safety.

In other recent news, Eli Lilly has received approval from the U.S. Food and Drug Administration for Inluriyo, an oral treatment for ESR1-mutated breast cancer. The Phase 3 EMBER-3 clinical trial showed that Inluriyo reduced the risk of disease progression or death by 38% compared to standard endocrine therapy. Additionally, Eli Lilly has opened a new biotech innovation hub in San Diego, expanding its network of facilities designed to support early-stage biotechnology companies. The 82,514-square-foot site can accommodate up to 15 life sciences companies and more than 250 employees.

On the financial front, TD Cowen and Guggenheim have both reiterated their Buy ratings on Eli Lilly stock, with price targets of $960 and $875, respectively. TD Cowen highlighted the company’s excellent growth prospects and consistent innovation, while Guggenheim noted strong growth projections for 2025, expecting sustainable gross margins of 82-83%. These developments reflect ongoing confidence in Eli Lilly’s performance and future potential.

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