USA — The Food and Drug Administration (FDA) has declined Eli Lilly’s application for its eczema drug, lebrikizumab, due to issues with a third-party manufacturing contractor responsible for producing the monoclonal drug substance.
The rejection, communicated by the company on Monday, marks the third setback for Eli Lilly in 2023.
While the FDA issued a complete response letter for lebrikizumab, it notably raised no concerns regarding the clinical data, safety, or labelling of the drug.
This latest rejection follows the FDA’s earlier refusals for Eli Lilly’s applications for mirkizumab, an ulcerative colitis medication, and the accelerated approval application for its Alzheimer’s drug, donanemab.
However, Eli Lilly remains committed to advancing lebrikizumab and intends to address the FDA’s cited issues.
Patrik Jonsson, Executive Vice President at Eli Lilly and President of Lilly Immunology and Lilly USA, expressed confidence in the drug’s potential to assist individuals with eczema.
He stated, “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.”
Despite encountering regulatory setbacks this year, Eli Lilly remains resolute in its drug development endeavours.
In January, the FDA issued a complete response letter for Eli Lilly’s submission of donanemab for accelerated approval, citing insufficient data on patients with at least 12 months of drug exposure.
The FDA requested additional data from at least 100 patients who had taken the drug for a year or more.
Eli Lilly did, however, announce promising results from the Phase 3 TRAILBLAZER-ALZ 2 study this summer, indicating that the drug significantly slowed cognitive and functional decline in individuals with early dementia. The company anticipates an FDA decision by the end of the year.
Eli Lilly had been banking on launching several drugs in 2023 to drive growth, including donanemab, mirikizumab, and lebrikizumab, along with the mantle cell lymphoma treatment, pirtobrutinib. Nevertheless, regulatory challenges have emerged for three of these drugs.
Despite these setbacks, Eli Lilly has found success with its diabetes drug, Mounjaro, which contributed to a 28% year-over-year increase in revenues, according to its latest earnings report.
Additionally, the company is testing an investigational weight loss drug, retatrutide, which demonstrated a 24% reduction in weight in Phase 2 data.
Furthermore, Eli Lilly has expanded its presence in the diabetes and obesity industry through acquisitions.
In June, the company acquired diabetes firm Sigilon Therapeutics for US$34 million and purchased obesity drugmaker Versanis for nearly US$2 billion.
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