The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Eli Lilly (ticker: LLY), stating concerns about their treatment for moderate-to-severe atopic eczema.
The CRL was prompted by findings from an inspection of a third-party manufacturing organization, which highlighted issues related to a substance used in lebrikizumab – a drug developed by Eli Lilly for the treatment of atopic dermatitis. As a result, the FDA has withheld approval of the drug pending further information.
Despite this setback, Eli Lilly clarified in a press release that the letter did not raise any concerns regarding the clinical data package, safety, or label for lebrikizumab.
In response to the news, premarket trading saw Eli Lilly’s stock dip slightly by 0.1% to $536.60.
It is worth noting that Eli Lilly’s stock has experienced significant growth this year, rising by an impressive 47%. This surge can be attributed to the high demand for their diabetes treatment, Mounjaro, which is hailed for its effectiveness in helping patients lose weight. Wall Street analysts have even predicted that Mounjaro has the potential to become the best-selling drug of all time.