Regulatory FDA Rejects Eli Lilly’s Bowel Disease Drug Citing Manufacturing...

FDA Rejects Eli Lilly’s Bowel Disease Drug Citing Manufacturing Issue


Eli Lilly’s mirikizumab, an IL-23 inhibitor, has recently been rejected by the Food and Drug Administration for the treatment of ulcerative colitis. The agency refused to approve the drug on grounds of issues related to manufacturing; however, no concerns regarding the clinical data package, safety, or label for the medicine were raised.

A spokesperson from the company has shared that they will be working with the FDA to address and resolve all concerns that were raised in the pre-approval inspection, and all future steps would be taken in collaboration with the regulator to understand exactly how much time it would take to address all observations, the representative further explained.

In a recent 12-day inspection in July, the FDA found several quality control shortfalls at Lilly’s plant in Branchburg, New Jersey, after which they issued a Form 483. The main concern was that potentially contaminated batches were not tracked properly. The FDA citation implicated many biologic drugs, including cancer drugs Erbitux and Cyramza and migraine drug Emgality.

There is no clear link between the Branchburg site problem and the mirikizumab rejection yet.

According to Morningstar analyst Damien Conover, “The setback is fairly minor from the context of what a great portfolio Eli Lilly has, and even within the drug itself, it sounds like it’s manufacturing issues, so I don’t think that’s going to be overly problematic.”

Ulcerative colitis is a medical condition that leads to the inflammation of the inner lining of the colon and the formation of ulcers due to an abnormal immune system response. This disease can cause abdominal pain and diarrhea as its major symptoms.

The market for the treatment of chronic inflammatory bowel disease in adults is worth nearly $20 billion, and the FDA’s rejection means that Lilly will have to wait some more before entering the said market.

Ulcerative colitis is a particularly competitive field, and Lilly will already have a tough time with rivals such as Abbvie Inc, Pfizer, and Johnson & Johnson in the game.

AbbVie’s anti-IL-23 star Skyrizi recently showed stellar results in a phase 3 trial where the treatment acted as an induction therapy in moderate to severe ulcerative colitis. The company plans to file the treatment for FDA approval this year. On the other hand, J&J’s IL-12/23 inhibitor Stelara is already approved for the disease.

Eli Lilly also faced a setback earlier this year when FDA refused to give an accelerated nod to the company’s Alzheimer’s disease drug, donanemab. For now, the firm is awaiting the FDA’s decision regarding its atopic dermatitis drug lebrikizumab. There are concerns that the drug may also face a negative response if it shares the same manufacturing site as mirikizumab.

Despite setbacks in the U.S., the European Medicines Agency’s positive opinion of the drug in the treatment of patients who were intolerant to any other treatment for moderate to severe ulcerative colitis has led the firm to believe that approval in Europe will come in the near future. The drug is already approved for use in Japan.

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