FDA Shuts Down Ulcerative Colitis Drug Approval Because of Manufacturing Issues

According to a story from MedCity News, the drug company Eli Lilly was anticipating the approval and launch of its drug mirikizumab as a treatment for ulcerative colitis. However, the US Food and Drug Administration (FDA) refused to approve the medication, citing manufacturing issues. The agency did not specify further, but rejections over manufacture of a complex therapy like mirikizumab are not unusual. The company sees further uses for the therapy, which has also been in development for Crohn’s disease, another form of inflammatory bowel disease.

About Ulcerative Colitis

Ulcerative colitis is a long-term condition which is characterized by the appearance of ulcers and generalized inflammation of the rectum and colon. The exact cause of the condition remains a mystery, but there do appear to be some risk factors, such as family history, diet, and exposure to the medication isotrentinoin. Smoking appears to have a slightly protective effect. Symptoms can include anemia, bloody diarrhea, weight loss, fever, and abdominal pain. They tend to appear in a relapsing-remitting pattern. In severe disease there is a risk of serious complications, such as megacolon or inflammatory disease in other parts of the body. The risk of colon cancer is also elevated. Treatment may include dietary changes, medication to control inflammation, and, when complications appear, surgery. To learn more about ulcerative colitis, click here.

About Mirikizumab

Mirikizumab is a monoclonal antibody designed to block interleukin-23 (IL-23), which is a protein associated with inflammation signaling, a central mechanism in ulcerative colitis. The therapy was able to induce remission in about half of patients in a phase 3 trial after one year. As the drug appears to have real efficacious potential, Eli Lilly intends to continue communicating with the FDA on finding a solution that results in approval. 

Mirikizumab recently won approval in Japan for ulcerative colitis, and it is also under review in Europe. Typically, manufacturing problems can eventually be fixed, but the rejection is still a major setback for the company. The monoclonal antibody is one of four drugs that the company was anticipating to see FDA approval this year.

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