Lilly(US:LLY) GLP1减重宝典·2026-01-19 12:14Core Viewpoint - The article discusses the delay in the FDA review process for Eli Lilly's oral GLP-1 drug, orforglipron, which was initially expected to be approved by late March but has now been pushed to April 10, 2024, impacting market expectations significantly [6][8]. Group 1: FDA Review Process - The FDA has extended the review period for several drugs, including orforglipron, which was anticipated to be a groundbreaking oral weight loss medication [6]. - The National Priority Voucher program aims to expedite the review process from 10-12 months to 1-2 months for drugs addressing significant medical needs, but safety and efficacy standards remain stringent [7]. - Other drugs facing similar review delays include Sanofi's Tzield, Disc Medicine's bitopertin, and Boehringer Ingelheim's zongertinib, indicating a broader trend in regulatory scrutiny [7]. Group 2: Market Implications - The delay in orforglipron's review alters the competitive landscape, especially against Novo Nordisk's Wegovy, which has already been launched and is gaining market share [8]. - Eli Lilly may need to rely on its existing injectable products to maintain market presence while awaiting the outcome of orforglipron's review [8]. - The situation underscores the importance of regulatory compliance and the challenges faced by pharmaceutical companies even in an environment that encourages innovation [8].