The U.S. Food and Drug Administration (FDA) has made a decision not to approve Eli Lilly’s drug, which was intended for the treatment of eczema. The reason behind this decision is related to findings made during an inspection of a contract manufacturer, as announced by the pharmaceutical company on Monday.
Importantly, the FDA’s feedback did not express any concerns regarding the clinical trial data, safety profile, or the labeling of the drug, lebrikizumab. Lebrikizumab is a monoclonal antibody developed for the treatment of atopic dermatitis, which is a common skin condition often referred to as eczema.
Eli Lilly has indicated its commitment to resolving the issues raised by the FDA. To address the concerns outlined in the FDA’s “complete response letter,” the company has pledged to collaborate closely with the third-party manufacturer and the regulatory agency itself.
The FDA’s decision not to approve Eli Lilly’s drug for atopic dermatitis is linked to findings during an inspection of a contract manufacturer. The drug itself, lebrikizumab, appears to have no issues related to its clinical efficacy, safety, or labeling. Eli Lilly is now focused on addressing the manufacturing concerns to eventually secure FDA approval for this skin disease treatment.