IBD drug market rattles as Lilly’s Omvoh nabs FDA approval for second IL-23p19 in Crohn’s
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The FDA has approved Omvoh for the treatment of moderately to severely active Crohn’s disease, making it the second interleukin-23p19 specific inhibitor approved for both major types of inflammatory bowel disease, Lilly reported.
Previously approved for ulcerative colitis in October 2023, Omvoh (mirikizumab-mrkz) enters an increasingly crowded IBD drug market following the approval of rival IL-23p19 inhibitor Skyrizi (risankizumab, AbbVie) in 2024, alongside the IL-12/23 blockbuster Stelara (ustekinumab, Janssen) and a logjam of its biosimilars set to release this year. Additionally, a third IL-23p19 inhibitor, Tremfya (guselkumab, Johnson & Johnson), is awaiting its own approval for Crohn’s disease.
“The approval of mirikizumab for Crohn’s disease provides us with more treatment options for our patients with IBD,” Edward V. Loftus Jr., MD, the Maxine and Jack Zarrow Family Professor of Gastroenterology at the Mayo Clinic and chief medical editor of Healio Gastroenterology, told Healio. “It will be interesting to parse through the clinical trial data to determine what – if any – differences there are between these anti-p19 antibodies among patients with Crohn’s disease and ulcerative colitis. It’s not yet clear what impact a second or third anti-p19 will have.”
Loftus noted, however, that this approval also raises questions: Will the availability of three IL-23p19 options lower drug prices? Will the second or third IL-23p19 options be used to treat patients who have failed the first or second?
The agency based its decision on data from the 52-week, phase 3 VIVID-1 trial, which assessed the efficacy of Omvoh in adults with moderately to severely active Crohn’s who failed to have an adequate response, experienced a loss of response or were intolerant to corticosteroids, immunomodulators and/or biologics.
Patients were administered IV Omvoh 900 mg at weeks 0, 4 and 8 received a subcutaneous maintenance dose of Omvoh 300 mg at week 12 followed by every 4 weeks for a total of 40 weeks. Those randomly assigned to placebo were switched to Omvoh if they did not achieve clinical response by 12 weeks.
According to VIVID-1 trial results, clinical remission at 1 year, defined by a Crohn’s Disease Activity Index less than 150, was achieved by 53% of patients who received Omvoh vs. 36% who received placebo. In addition, 46% of patients treated with Omvoh patients achieved endoscopic response with “visible healing of the intestinal lining” vs. 23% of those treated with placebo. At 3 months, early improvement in endoscopic response was observed in 32% of patients in the Omvoh group vs. 11% in the placebo group.
The efficacy and safety of Omvoh are being further assessed in the ongoing, open-label extension VIVID-2 trial in those with moderately to severely active Crohn’s disease.
Results from the VIVID-2 trial showed that more than 80% of patients who achieved endoscopic response after 1 year of Omvoh treatment were able to maintain response following 1 year of additional treatment or 2 years of continuous treatment; approximately 90% were able to maintain clinical remission.
“Many patients with Crohn's disease have tried available therapies and are still seeking a treatment option that can work well for them to help control their disease,” Marla Dubinsky, MD, chief of the division of pediatric gastroenterology and nutrition at Mount Sinai Kravis Children’s Hospital and co-director of the Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center, said in the release. “The FDA approval of Omvoh may help adults with Crohn’s disease achieve long-term remission and visible healing of the intestinal lining, even if they have tried other medications that did not work or stopped working.”
Data from both VIVID-1 and VIVID-2 demonstrated that Omvoh’s safety profile in patients with Crohn’s was “generally consistent” with the profile observed in those with UC. Common adverse reactions included upper respiratory tract infections, injection site reactions, headache, arthralgia and elevated liver tests. In addition, the Omvoh labeling includes warnings and precautions for hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity and immunizations.
The company noted it has submitted additional marketing applications for Omvoh for the treatment of Crohn’s in the EU and Japan, and is planning to submit more regulatory applications.
As of Jan.1, Lilly was able to obtain first-line biologic coverage for Omvoh from two large pharmacy benefit managers, meaning it will be available on “formulary in the preferred specialty tier, alongside other products, and does not require failure of other biologic agents prior to use,” the release stated.
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