Omvoh is an IL-23p19 antagonist, approved to treat moderate to severely active ulcerative colitis (UC) in adults, based on results from the LUCENT programme, which includes two randomised, placebo-controlled Phase 3 trials, UC-1 and UC-2
Eli Lilly and Company’s corporate Center in Indiana, US. (Credit: Momoneymoproblemz/Wikipedia)
Eli Lilly and Company has received the US Food and Drug Administration (FDA) approval for Omvoh (mirikizumab-mrkz) to treat moderate to severely active ulcerative colitis (UC) in adults.
Omvoh is a humanised antibody therapeutic that selectively targets the p19 subunit of interleukin-23 (IL-23) and inhibits the IL-23 pathway.
The US FDA approved the drug for 300mg/15mL infusion, once every four weeks for three infusions, followed by 100mg subcutaneous self-injections, every four weeks for injections.
Lilly said that it is the only UC treatment that selectively targets the p19 subunit of IL-23, which plays a key role in inflammation related to UC.
Lilly executive vice president, Lilly Immunology president, and Lilly USA chief customer officer Patrik Jonsson said: “Omvoh addresses key symptoms that matter most to patients and represents our patient-centric approach to treatment innovation.
“Omvoh’s approval is a significant moment for Lilly’s growing Immunology portfolio, and we are excited to work with the gastroenterology community to set high expectations of care for people living with ulcerative colitis.”
The FDA approval was supported by results from the LUCENT programme, which includes two randomised, double-blind, placebo-controlled Phase 3 trials in previously treated patients.
The two Phase 3 clinical trials include a 12-week induction study (UC-1) and a 40-week maintenance study (UC-2) for 52 weeks of continuous treatment.
In the studies, treatment using Omvoh achieved clinical response in 65% of patients, and clinical remission in 24%, compared to 43% and 15% for placebo, after 12 weeks.
The most common adverse reactions include upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.
Omvoh is not recommended for patients with a history of serious hypersensitivity reaction to the drug or any of its excipients.
It comes with a labelled warning for hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity, and immunisations.
Lilly has already secured regulatory approval for Omvoh in Japan and the European Union (EU) this year and expects regulatory approvals from additional markets around the world soon.
The US drugmaker intends to start commercialising the drug in the US in the next few weeks.