Hua Er Jie Jian Wen·2025-12-12 13:34Core Viewpoint - The FDA is under internal pressure to expedite the review process for Eli Lilly's oral weight-loss drug, Orforglipron, potentially allowing for an approval decision as early as March 28, 2026, instead of the previously scheduled May 20, 2026 [1][2]. Group 1: FDA Review Process - The FDA is considering reducing the review period for Orforglipron from 60 days to just 1 week to accelerate its market entry [1][2]. - Eli Lilly's participation in the FDA's "National Priority Voucher" program aims to fast-track the approval process due to the drug's potential public health significance [2]. - Despite the push for a faster review, the FDA's review team insists on adhering to the existing six-month review cycle, citing the need for thorough safety evaluations [2]. Group 2: Competitive Landscape - Eli Lilly's Orforglipron has shown an average weight loss of 12.4% in clinical trials, positioning it as a significant contender in the obesity treatment market, which is valued at $150 billion [1]. - Competitor Novo Nordisk plans to launch its oral weight-loss drug in December or January, intensifying the competition between the two pharmaceutical giants [1][3]. - The ongoing competition is expected to heighten regulatory scrutiny and redefine the balance between efficiency and safety in drug approvals [3].