The U.S. Food and Drug Administration (FDA) has approved Mirikizumab-mrkz for the treatment of moderately to severely active Crohn’s disease in adults. This marks its second approval for inflammatory bowel disease (IBD) following its October 2023 approval as a first-in-class treatment for ulcerative colitis (UC) in adults.

Mirikizumab-mrkz targets interleukin-23p19 (IL-23p19), a key protein contributing to intestinal inflammation. It is the first biologic in over 15 years to disclose two-year Phase 3 efficacy data for Crohn’s disease at the time of approval.

Key Clinical Trial Findings

The approval is based on results from the Phase 3 VIVID-1 study, which included patients with moderately to severely active Crohn’s disease who showed an inadequate response to corticosteroids, immunomodulators, or biologics. This randomized placebo-controlled trial evaluated the efficacy of Mirikizumab-mrkz and achieved the following results:

• Clinical remission at one year: 53% of patients treated with Mirikizumab-mrkz achieved clinical remission versus 36% on placebo (p<0.001).
• Endoscopic response at one year: 46% of patients achieved visible healing of the intestinal lining versus 23% on placebo (p<0.001).

Additionally, 32% of patients treated with Mirikizumab-mrkz showed early improvement in endoscopic response by three months, compared to 11% on placebo (p<0.001).

The VIVID-2 open-label extension (OLE) study further demonstrated the treatment's long-term efficacy. Among patients achieving endoscopic response at one year in VIVID-1, over 80% maintained their response with an additional year of treatment. Nearly 90% of patients who achieved both clinical remission and endoscopic response at one year maintained clinical remission after two years of continuous treatment.

Safety Profile

The overall safety profile of Mirikizumab-mrkz in Crohn’s disease aligns with its known safety profile in UC. Common side effects (≥5% of patients) include upper respiratory tract infections, injection site reactions, headaches, arthralgia, and elevated liver tests. Warnings include hypersensitivity reactions, infection risks, tuberculosis, hepatotoxicity, and immunizations.

Expert Opinions

“Crohn’s disease significantly impacts patients’ daily lives,” said Michael Osso, president and CEO of the Crohn’s & Colitis Foundation. “This approval provides meaningful options for adult patients seeking better disease control.”

Dr. Marla Dubinsky, co-director of the IBD Clinical Center at Mount Sinai, highlighted the importance of this approval: “The FDA approval of Mirikizumab-mrkz may help patients achieve long-term remission and visible healing of the intestinal lining, even if other medications have failed.”

Expanding Global Access

Lilly has submitted marketing applications for Mirikizumab-mrkz in the European Union, Japan, and other markets. Currently, it is approved in 44 countries for ulcerative colitis and continues to gain regulatory approvals worldwide for Crohn’s disease.

Patient Support and Accessibility

Lilly is working with insurers and health systems to ensure access to Mirikizumab-mrkz. As of January 1, it has secured first-line biologic coverage from two of the three largest pharmacy benefit managers. The company also offers co-pay assistance and patient support programs through Lilly Support Services™.

“Symptoms like abdominal pain, frequent bowel movements, and bowel urgency are highly disruptive,” said Dr. Daniel Skovronsky, chief scientific officer and president of Lilly Research Laboratories. “Mirikizumab-mrkz provides long-term disease control, reflecting our commitment to improving outcomes for patients with Crohn’s disease and UC.”