Eli Lilly says weight-loss pill a candidate for speedy approval under new US program

Core Insights - Eli Lilly's experimental weight-loss pill, orforglipron, is a strong candidate for accelerated FDA approval due to meeting most criteria for the new national priority voucher program [1][2] - The FDA's new program allows for expedited reviews of priority drugs, reducing the review time from approximately 10-12 months to 1-2 months [2] - Eli Lilly's GLP-1 pill demonstrated a significant weight loss of 12.4% in late-stage studies, and the company has invested billions in U.S. manufacturing plants for this product [3] Financial Performance - Eli Lilly raised its full-year profit and revenue forecasts, driven by strong international demand for weight-loss drugs, surpassing Wall Street's earnings expectations for the third quarter [4] - International sales of Mounjaro, the brand name for the weight-loss drug outside the U.S., exceeded Guggenheim analysts' estimates by nearly $1 billion for the quarter [6] - Approximately 75% of Mounjaro's revenue from international markets comes from out-of-pocket payments by individuals with obesity [6] Market Competition - Eli Lilly is competing with Novo Nordisk in the weight-loss drug market, which is projected to reach $150 billion by the end of the decade [7] - The company faces potential challenges from drug price negotiations under the Trump administration, which aims to align U.S. drug prices with those in other developed nations [4][7]