Eli Lilly and Co. (LLY), on Friday, announced that most patients with moderately to severely active Crohn's disease treated with Omvoh for two years, experienced sustained clinical remission and endoscopic response.
The findings were based on the VIVID-2 open-label extension study, which is evaluating the e?cacy and safety of Omvoh for up to three years in adults with moderately to severely active Crohn's disease.
According to the study results, more than 90 percent of patients who were in clinical remission for one year sustained it with two years of continuous treatment.
Nearly 90 percent of those who achieved endoscopic response at one year sustained their improvement at two years of treatment.
Key Findings from the Updated Data:
-- 92.9 percent of patients in clinical remission at one year maintained clinical remission at two years, as measured by the Crohn's Disease Activity Index or CDAI.
-- 87.6 percent of patients treated in VIVID-2 maintained endoscopic response, defined by a =50 percent reduction from baseline in the Simple Endoscopic Score for Crohn's Disease or SES-CD.
-- 78.6 percent of patients who were in endoscopic remission at one year maintained endoscopic remission at two years.
-- Among patients who were not in clinical remission at one year, 60.8 percent achieved clinical remission during the second year of treatment.
-- Among those not in endoscopic remission at one year, 35.4 percent gained endoscopic remission during the second year of treatment.
The safety profile of Omvoh was consistent with previous findings, with 6.8 percent of patients with endoscopic response at one year reporting a serious adverse event and 0.8 percent discontinuing treatment due to adverse events.
Omvoh was approved by the FDA in 2023 for the treatment of ulcerative colitis and in January 2025 for the treatment of moderately to severely active Crohn's disease.
The drug was approved by the European Medicines Agency for ulcerative colitis in June 2023. The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion for the drug for the treatment of adults with moderately to severely active Crohn's disease in December 2024.
Eli Lilly is progressing with global regulatory submissions in Canada, Japan, and China, and has ongoing studies to evaluate Omvoh's long-term efficacy and safety in pediatric and adult populations.
LLY closed Thursday's (FEB.06 2025) trading at $870.37 up by 3.35%. In premarket trading Friday the stock is up by 0.20% at $872.10.
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