United States: The US Food and Drug Administration has granted approval for mirikizumab-mrkz, sold as Omvoh by Eli Lilly and Company, as a treatment for moderately to severely active Crohn’s disease in adults.
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Omvoh binds to interleukin 23p19, which is involved in the regulation of inflammation in the intestines.
Omvoh is the first Crohn’s disease biological company to submit phase 3 efficacy data for two years of treatment in more than 15 years.
$LLY Omvoh is now FDA-approved for treating moderately to severely active Crohn’s disease in adults, providing a new treatment option for patients: https://t.co/n2UHa0Y3UH#Omvoh #CrohnsDisease #IBD #FDAApproval #EliLilly #HealthcareInnovation
— BioMedWire (@BioMedWire) January 17, 2025
The approval has been achieved thanks to the results of the multicenter, double-blind, placebo-controlled, phase 3 VIVID-1 trial involving adult patients with moderately to severely active Crohn’s disease, intolerant or having failed corticosteroids, immunomodulators, and/or biologic agents.
For this investigation, patients were randomly allocated to a placebo or Omvoh.
Details of the study
The patients in the placebo arm who did not respond clinically at 12 weeks were then crossed over to active drug treatment Omvoh.
Both primary endpoints were attained; 53 and 36 percent of patients treated with Omvoh were in clinical remission at one year, and 46 and 23 percent of patients treated with Omvoh and placebo, respectively, presented discernible healing of the intestinal lining at one year.
FDA Approves Omvoh for Moderately to Severely Active Crohn Disease https://t.co/U0Q9U9j8NQ
— Drugs.com (@Drugscom) January 17, 2025
According to Daniel M. Skovronsky, M.D., Ph.D., chief scientific officer and president of Lilly Research Laboratories and Lilly Immunology, “With Omvoh approved in both Crohn’s disease and ulcerative colitis, more patients now have a treatment option that may provide long-term disease control and address key symptoms that matter most to them, reflecting Lilly’s ongoing commitment to elevate care and improve outcomes for patients,” US News reported.