Eli Lilly has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for lebrikizumab’s biologic licence application (BLA) for the treatment of atopic dermatitis or eczema.
The FDA didn’t raise any issues with the clinical safety package, safety or label for the drug, and no other Lilly products are implicated.
This news marks Lilly’s third CRL of 2023, with prior ones dealing with mirikizumab and donanemab.
Back in April, the FDA declined to approve Lilly’s mirikizumab for the treatment of ulcerative colitis, raising issues related to the manufacturing of the drug. It is not clear whether the manufacturing concerns between lebrikizumab and mirikizumab are related.
This came a few months after the FDA rejected an accelerated approval application for donanemab as a treatment for Alzheimer’s disease back in January. A spokesperson for Lilly at the time stated: “We are working with the FDA to ensure the fastest possible path to bring this potential medicine to patients in need.” The drug was rejected due to concerns about an insufficient quantity of clinical trial data. Since then, the company has filed for full approval following Phase III results, and said it expects an approval decision on donanemab by end of 2023.
Lebrikizumab is a humanised monoclonal antibody that is intended to treat patients with moderate to severe atopic dermatitis. According to GlobalData, lebrikizumab is forecast to have sales worth over $3bn by 2029.
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Patrik Jonsson, Lilly executive vice president, president of Lilly immunology and Lilly USA, and chief customer officer said: “We will continue to work closely with the third-party manufacturer and the FDA to address the feedback in order to make lebrikizumab available to patients.”