The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Eli Lilly (LLY), expressing concerns about their treatment for moderate-to-severe atopic eczema.
The CRL was prompted by findings that emerged during an inspection of a third-party contract-manufacturing organization. This inspection included a substance used in lebrikizumab, a drug developed by Eli Lilly to treat atopic dermatitis. As of now, the FDA has not approved the drug, as they have some outstanding questions.
Despite this setback, the FDA's concerns do not involve the clinical data package, safety, or labeling of lebrikizumab, according to a press release by Eli Lilly.
Following the news, Eli Lilly's stock experienced a slight dip of 0.1% in premarket trading on Monday. However, the company's shares have had an impressive year, surging by 47%. Investors have been particularly optimistic about Eli Lilly's diabetes treatment Mounjaro, which also aids in weight loss. Analysts on Wall Street have even predicted that Mounjaro will become the highest-selling drug of all time.