Eli Lilly’s bowel disease drug rejected by FDA after surprise Alzheimer’s drug rejection

USA — The United States Food and Drug Administration (FDA) has declined Eli Lilly and Company’s latest drug, which aimed to treat chronic inflammatory bowel disease in adults, as announced by the leading pharmaceutical firm.

Ulcerative colitis is a chronic condition characterized by inflammation and ulcers in the colon lining, often leading to symptoms such as diarrhea, abdominal pain, and passing of blood with stool.

This setback is likely to pose a significant challenge to the company’s efforts to penetrate the lucrative market, which is estimated to be worth nearly US$20 billion and already has competing drugs from established players such as Abbvie Inc., Pfizer Inc., and Johnson & Johnson.

The FDA’s decision to reject Eli Lilly’s drug, known as mirikizumab, is primarily attributed to manufacturing-related concerns, and not because of any misgivings regarding the clinical data package, safety, or label for the medicine, according to Lilly’s statement.

Mirikizumab, Eli Lilly and Company’s drug candidate for chronic inflammatory bowel disease, is an IL-23 inhibitor.

This mechanism of action is also utilized by AbbVie’s Skyrizi, which has shown promise in phase 3 trials as an induction therapy for moderate to severe ulcerative colitis.

While the FDA’s stance presents a formidable obstacle for the company, Lilly remains optimistic about the drug’s potential, which it had identified as one of its significant sources of growth in the coming years.

Lilly had identified this drug as one of its major sources of growth in the coming years, making this a significant blow to the company’s plans.

Earlier this year, Eli Lilly faced another setback when the FDA declined to grant accelerated approval for its Alzheimer’s disease drug, donanemab, which may slow down the company’s launch plans for the drug.

Nonetheless, Lilly has several other highly anticipated launches planned for 2023, including tirzepatide for obesity, lebrikizumab for atopic dermatitis or eczema, and pirtobrutinib for cancer treatment.

While the company may be facing some setbacks, its continued focus on research and development suggests that it remains committed to bringing much-needed medications to market.

Additionally, Johnson & Johnson is also progressing with its IL-23 inhibitor Tremfya in the treatment of inflammatory bowel disease.

The market for ulcerative colitis is fiercely competitive, with J&J’s Stelara, an IL-12/23 inhibitor, already approved for use in the disease.

Furthermore, small-molecule drugs like AbbVie’s Rinvoq, a JAK inhibitor, and Bristol Myers Squibb’s S1P modulator Zeposia are currently available.

Pfizer also plans to seek approval for its own S1P drug, etrasimod, while other drugs are in the process of being developed through phase 2 or phase 3 trials.

In addition to its application in ulcerative colitis, Eli Lilly and Company is testing mirikizumab as a potential treatment for Crohn’s disease, the other subtype of inflammatory bowel disease, in a phase 3 clinical trial.

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