Breaking News: Lilly’s OMVoh Mirikizumab Receives Green Light from CHMP for EU Approval in Treating Crohn’s Disease in Adults
Description:
The Phase 3 VIVID-1 trial evaluated the safety and efficacy of Omvoh in patients with or without prior biologic failure and was the basis for the positive opinion. VIVID-1 was the first pivotal Crohn’s disease trial to show benefits in hard-to-treat symptom of bowel urgency using a patient-centric scale. Omvoh will be the first treatment for Crohn’s disease with results demonstrating improvements of histologic measures of inflammation included in its label, if approved by the European Commission. Lilly has also submitted Omvoh in the U.S. for approval to treat adults with moderately to severely active Crohn’s disease, with a decision expected in the first half of 2025. INDIANAPOLIS, Dec. 13, 2024 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Omvoh® (mirikizumab), an interleukin-23p19 (IL-23p19) antagonist, for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment. “I am excited for the potential of Omvoh as a novel treatment option for patients suffering from moderately to severely active Crohn’s disease, since the majority of patients do not achieve remission on current therapies or cannot maintain it long term,” said Stefan Schreiber, M.D.
Impact on Me:
As a patient suffering from moderately to severely active Crohn’s disease, the approval of Omvoh by the CHMP for EU approval provides hope for a new treatment option. With the potential benefits demonstrated in the Phase 3 VIVID-1 trial, Omvoh could offer improvements in symptom management and histologic measures of inflammation, providing a new avenue for achieving remission and long-term maintenance of the disease.
Impact on the World:
The approval of Omvoh by the CHMP for EU approval signifies a significant advancement in the treatment of Crohn’s disease for adults. With the potential of Omvoh to address hard-to-treat symptoms and offer improvements in histologic measures of inflammation, this novel treatment option could potentially benefit a larger population of patients worldwide, contributing to better outcomes and quality of life for those suffering from this chronic condition.
Conclusion:
In conclusion, the positive opinion issued by the CHMP for Omvoh represents a promising development in the field of Crohn’s disease treatment. With the potential for improved symptom management and histologic measures of inflammation, Omvoh offers hope for patients looking for new options to achieve remission and long-term relief from the burdens of this condition.
