The pharmaceutical company says the letter cited no worries about the safety of its lebrikizumab skin treatment.
The U.S. Food and Drug Administration sent Eli Lilly a Complete Response Letter citing concerns regarding its treatment for moderate-to-severe atopic eczema.
On Monday, Eli Lilly said the FDA issued the so-called CRL because of findings that arose during an inspection of a third-party, contract-manufacturing organization that included a substance used in lebrikizumab—a drug to treat atopic dermatitis. The letter means the regulator has outstanding questions and for now has declined to approve the drug.
“The letter stated no concerns about the clinical data package, safety, or label for lebrikizumab,” the company said in a press release.Shares of Eli Lilly have soared this year, rising 47%. Investors have been enthused by the demand for diabetes treatment Mounjaro that also helps patients lose body weight. Wall Street analysts have previously projected Lilly’s Mounjaro will be the best-selling drug of all time.
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