FDA rejects Eli Lilly’s mirikizumab for ulcerative colitis, citing manufacturing concerns

Title: FDA Rejects Eli Lilly’s Mirikizumab for Ulcerative Colitis: Manufacturing Concerns


The FDA (U.S. Food and Drug Administration) has recently rejected Eli Lilly’s application for approval of mirikizumab as a treatment for ulcerative colitis. The decision was based on concerns over the manufacturing processes involves in producing the drug. In this blog post, we will delve into the key points surrounding the FDA’s decision, the implications for Eli Lilly, and the potential impact on patients.

Key Points:

  1. Understanding Mirikizumab:
    Mirikizumab is an immunology drug under development by Eli Lilly, mainly designed to treat the symptoms of inflammatory bowel disease (IBD). The drug works by targeting a protein called interleukin-23 (IL-23), a key contributor to the chronic inflammation that leads to IBD, including ulcerative colitis. It belongs to a new class of drugs called IL-23 inhibitors and has shown promising results in clinical trials.
  2. FDA’s Manufacturing Concerns:
    The FDA’s rejection of Eli Lilly’s mirikizumab application was primarily due to concerns over the manufacturing processes involved in producing the drug. According to the FDA, Eli Lilly had failed to demonstrate that the manufacturing processes were sufficient to ensure consistent and adequate drug product quality. The inspection also found deficiencies in the facility’s control systems, which could impact the drug’s efficacy and safety.
  3. Eli Lilly’s Response:
    Eli Lilly has responded positively to the FDA’s decision, stating its commitment to addressing the manufacturing concerns raised by the agency promptly. The company has released a statement indicating that it is working closely with the FDA and expects to address these issues within a short period. The company further stated its continued commitment to developing new treatment options for ulcerative colitis patients and other inflammatory bowel conditions.
  4. Impact on Eli Lilly:
    The FDA’s rejection of Eli Lilly’s application for mirikizumab will likely have negative financial implications for the company. The loss of a potential revenue-generating drug is a significant setback for any pharmaceutical company. Eli Lilly had high hopes for mirikizumab, citing the drug’s potential to generate up to $1 billion in revenue annually. The delay in approval will likely be a blow to both the company and its investors.
  5. Impact on Patients:
    The rejection of Eli Lilly’s mirikizumab will affect the many patients seeking new and effective treatment options for ulcerative colitis. The drug’s potential to improve the quality of life for ulcerative colitis patients was significant, and the delay in approval is disappointing news for those living with this condition. Ulcerative colitis is a chronic disease with no known cure, and the delay in getting a new drug in the market is a setback for patients and healthcare providers.
  6. Next Steps:
    The FDA’s rejection of mirikizumab to treat ulcerative colitis will likely delay Eli Lilly’s plans to bring the drug to market, but it is not necessarily the end of the road. Eli Lilly has the opportunity to address the FDA’s concerns over the manufacturing processes and resubmit its application for reconsideration. The company has already stated its commitment to working with the FDA to resolve the issues promptly. In the meantime, patients and their healthcare providers must continue to explore other treatment options and manage the condition accordingly.


The FDA’s rejection of Eli Lilly’s mirikizumab application for treating ulcerative colitis is a significant setback for both the pharmaceutical company and the many patients seeking new and effective ways to manage this chronic condition. While the manufacturing concerns raised by the FDA must be addressed, it is important to continue the search for new and improved treatment options for ulcerative colitis. The pharmaceutical industry and regulatory agencies must continue to work together to ensure that patients have access to safe and effective treatment options. In the meantime, those living with ulcerative colitis and other inflammatory bowel conditions must continue to work with their healthcare providers to manage the disease.