Eli Lilly eczema drug lebrikizumab rejected by USFDA
Indianapolis: The U.S. Food and Drug Administration (FDA) has declined to approve Eli Lilly's drug to treat a type of skin disease due to certain findings during an inspection of a contract manufacturer, the drugmaker said on Monday.
The company said the agency did not raise concerns about the clinical trial data, safety or label for lebrikizumab, a monoclonal antibody for treatment of atopic dermatitis, or eczema.
The company said it will work with the manufacturer and the FDA to address the issues cited by the regulator in its so-called complete response letter.
A spokesperson for Lilly declined to provide more details on the findings of the FDA and the contract manufacturer.
Lebrikizumab was one of the five treatments that Eli Lilly was hoping to launch this year. The others include donanemab to treat Alzheimer's disease and tirzepatide for obesity.
It had sought approval for lebrikizumab based on three studies involving over 1,000 patients with moderate-to-severe eczema who were unable to control their symptoms with topical medicines or other systemic treatments.
Analysts, on average, estimate lebrikizumab to generate $1.64 billion in sales in 2026, according to LSEG data.
Atopic dermatitis has multiple treatments available, including those by AbbVie and Pfizer as well as some generic drugs like cetirizine
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