Opening the Door: Omvoh

In October 2023, the FDA announced the approval of Omvoh for the treatment of moderately to severely active ulcerative colitis (UC) in adults. Typically, biopharma manufacturers celebrate this kind of news. For Eli Lilly, the moment was more exciting than normal. Omvoh, also known as mirikizumab-mrkz, was a promising medicine for patients suffering from inflammatory bowel diseases, but, unfortunately, for UC, its path to commercialization was temporarily delayed.

In April 2023, the FDA rejected mirikizumab due to the proposed manufacturing of the drug, according to a complete response letter from the agency at the time. The FDA noted that it did not have any concerns about the clinical data package, drug safety, or label.¹

This news came as a surprise, as Omvoh had been approved in Japan and European markets by that point.

In a press release at the time, Patrik Jonsson, executive vice president and president of immunology, Lilly, and Lilly USA, and chief customer officer, stated, “We remain confident in mirikizumab’s pivotal Phase III clinical data and its potential to help people with ulcerative colitis. We are working diligently with the FDA and hope to launch mirikizumab in the US as soon as possible.”

Renewed hopes for approval in the UC indication likely grew in October 2023 when Lilly announced the results of a clinical trial that showed Omvoh’s effectiveness for patients with Crohn’s disease. Those who participated in the VIVID-1 Phase III study who received mirikizumab were more likely to show a clinical response and remission after 52 weeks compared to the placebo group.²

Pharmaceutical Executive spoke with Mark Genovese, MD, senior vice president of immunology development, Lilly, about the impact that conditions such as Crohn’s disease and UC have on patients.

“First, there is the pain and discomfort that comes with these conditions, and that can come in waves or be chronic,” he says. “The second issue could be the frequent diarrhea that patients experience. The unpredictability can majorly impact your vocational and avocational activities. A third issue to think about is the weight loss and malnutrition. Given that loss of material through the gut, this can result in malnutrition, low energy, unintended weight loss, and fatigue. Some patients will go on to have other complications, such as bowel obstructions, which require additional surgeries. There are other impacts, such as depression, anxiety, and the reduction of the overall quality of life.”

Just two weeks after disclosing Omvoh’s favorable data in Crohn’s disease, Lilly, having addressed the issues in the complete response letter, would gain FDA approval in UC.³ Omvoh became the only treatment for the disease that targets the subunit of IL-23, which plays a role in inflammation.

With news of the approval, Jonsson issued a statement saying, “Omvoh addresses key symptoms that matter most to patients (i.e., stool frequency, rectal bleeding, bowel urgency) 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 approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase III trials. According to Lilly, after 12 weeks of treatment with Omvoh, nearly two-thirds (65%) of patients achieved clinical response and nearly one-fourth (24%) achieved clinical remission compared to placebo.

“I see many people with ulcerative colitis who previously tried other biologic treatments, and they are still searching for an effective option that can offer rapid and lasting improvements,” said Bruce Sands, MD, Dr. Burrill B. Crohn Professor of Medicine and chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, in a press release. “[The] approval represents a novel scientific advancement.”

Omvoh’s brand website⁴ features a section where patients can submit their stories about treatment experience. According to the site, these stories may be used in Lilly materials to help motivate others to consider the medication. UC can trigger a severe amount of pain and discomfort, but often in ways that people are uncomfortable discussing. By giving a place for people to share their stories, the hope is that users will be more open about the truth of their condition and the treatment.

“It’s a difficult thing to talk about,” Genovese told Pharm Exec. “Folks don’t like to discuss their bowel habits and how they impact their normal day. They don’t like to talk about it with friends or at the workplace, but they’re also uncomfortable bringing it up at the doctor’s office. Finding an outlet where people can actually voice their concerns and how it impacts them is important.”

References

1. U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab. PR Newswire. April 13, 2023. https://www.prnewswire.com/news-releases/us-food-and-drug-administration-issues-complete-response-letter-for-mirikizumab-301796847.html

2. Lilly's Mirikizumab Helped Patients with Crohn's Disease Achieve Long-Term Remission in Phase III Trial. PR Newswire. October 12, 2023. https://www.prnewswire.com/news-releases/lillys-mirikizumab-helped-patients-with-crohns-disease-achieve-long-term-remission-in-phase-3-trial-301954471.html

3. FDA Approves Lilly's Omvoh™ (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis. PR Newswire. October 26, 2023. https://www.prnewswire.com/news-releases/fda-approves-lillys-omvoh-mirikizumab-mrkz-a-first-in-class-treatment-for-adults-with-moderately-to-severely-active-ulcerative-colitis-301969505.html

4. Omvoh product page. Eli Lilly and Company. https://omvoh.lilly.com/