This weight-loss pill by Lilly could be FDA-approved by end of 2025

Core Viewpoint - Eli Lilly's experimental weight-loss pill, orforglipron, may be fast-tracked for approval by the FDA under a new review process, potentially leading to significant revenue increases for the company [2][4][5]. Drug Development and Approval - The FDA has introduced a "Commissioner's National Priority Voucher" program that allows for expedited review of certain experimental drugs, reducing the approval timeline from 10 months to one or two months [5][9]. - Analysts believe orforglipron is a strong candidate for this expedited review due to its potential to address a high-burden chronic condition and its competitive pricing strategy [8][11]. Market Context - The U.S. market for weight-loss drugs is under pressure due to the high costs of existing injectable options, with Lilly's injected drug priced at nearly $8,000 annually [7][10]. - Approximately 40% of U.S. adults are classified as obese, highlighting the significant public health need for effective weight-loss treatments [7]. Financial Implications - Goldman Sachs estimates that an earlier launch of orforglipron could generate an additional $1 billion in revenue for Lilly [4]. - The potential U.S. net price for new GLP-1 obesity pills is projected to be around $400 per month, which could enhance patient access and competitive positioning [12]. Competitive Landscape - Orforglipron is designed to mimic the appetite-suppressing GLP-1 hormone, similar to Lilly's existing products and those from competitors like Novo Nordisk [10][11]. - Analysts predict that the global market for GLP-1 obesity drugs could reach annual sales of $150 billion by the end of the decade, indicating a lucrative opportunity for Lilly [10].