- The FDA has issued a complete response letter for Eli Lilly And Co's LLY mirikizumab biologic license application (BLA) for ulcerative colitis (UC).
- In the letter, the FDA cited issues related to the proposed manufacturing of mirikizumab, with no concerns about the clinical data package, safety, or label for the medicine.
- Reuters writes that FDA's decision puts Lilly further behind in its quest to enter the nearly $20 billion market, which already has drugs for the disease from Abbvie Inc ABBV, Pfizer Inc PFE and Johnson & Johnson JNJ.
- Lilly recently received approval for mirikizumab as a first-in-class treatment for adults with moderately to severely active UC in Japan.
- The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for mirikizumab for UC patients who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
- "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," Morningstar analyst Damien Conover told Reuters.
- The FDA issued a complete response letter for the accelerated approval submission of Eli Lilly's donanemab for early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission.
- Price Action: LLY shares are down 0.29% at $369.05 during the premarket session on the last check Friday.
- Photo via Wikimedia Commons
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