Lilly's Autoimmune Drug Lebrikizumab Rejected by FDA Due to Manufacturing Issues

According to relevant data statistics, the global autoimmune disease drug market reached $127.7 billion in 2021 and is estimated to reach $176 billion by 2030. The large patient population has attracted multinational corporations (MNCs) to continuously enter the market, with Eli Lilly being one of the representatives. On October 2, the FDA announced the rejection of Eli Lilly's Biologics License Application (BLA) for Lebrikizumab, intended for treating moderate to severe atopic dermatitis (eczema). The main reason was issues found with a third-party contract manufacturing organization (CMO) during inspections.