The U.S. Food and Drug Administration (FDA) has declined to approve Eli Lilly’s monoclonal antibody lebrikizumab to treat patients with moderate-to-severe eczema, according to an article published in Reuters. The FDA’s decision comes after findings during an inspection of a contract manufacturer. Eli Lilly hoped to receive approval for the agent on the basis of three clinical studies that demonstrated benefit in patients with moderate-to-severe eczema who did not respond to treatment with other systemic therapies, and hopes to work with the FDA to resolve the issues.
October 11, 2023