News Brief: FDA Approves First GLP-1 Obesity Pill
Summary
The U.S. FDA has approved Novo Nordisk’s oral semaglutide, the first GLP-1 pill for obesity treatment. Priced at $149/month for the starting dose, it launches in early 2026 and also reduces cardiovascular risk. This gives Novo a lead over rival Eli Lilly in the expanding obesity drug market.
Key Points
- Landmark Approval: First-ever GLP-1 pill for obesity, also approved to reduce risk of heart attack, stroke, or death in obese adults with cardiovascular disease.
- Availability & Price: Starting 1.5mg dose available early January 2026 via pharmacies/telehealth at $149/month. Higher dose pricing undisclosed.
- Efficacy: In trials, a 25mg dose led to average weight loss of up to 16.6% after 64 weeks.
- Market Dynamics: Novo gains first-mover advantage over Eli Lilly, which is developing its own pill. Pills are seen as the next major battleground in the lucrative GLP-1 market.
- Patient Access: Pill format may attract patients hesitant about injections. Price aims to compete with unapproved, compounded copycat drugs.
- Administration Note: Must be taken on an empty stomach, waiting 30 minutes before eating/drinking.
新闻简报：FDA批准首款GLP-1肥胖症口服药
摘要
美国FDA已批准诺和诺德的口服司美格鲁肽，这是首款用于治疗肥胖症的GLP-1口服药物。起始剂量定价为每月149美元，将于2026年初上市，同时也能降低心血管风险。这使诺和诺德在竞争激烈的肥胖症药物市场中领先于主要竞争对手礼来公司。
关键点
- 里程碑式批准：首款用于肥胖症的GLP-1口服药，同时获批用于降低患有心血管疾病的肥胖成人发生心脏病、中风或死亡的风险。
- 可用性与价格：1.5毫克起始剂量将于2026年1月初通过药房和特定远程医疗提供商提供，优惠价为每月149美元。更高剂量的价格未公布。
- 疗效：试验中，25毫克剂量在64周后平均减重高达16.6%。
- 市场动态：诺和诺德获得对礼来公司的先发优势，礼来正在开发自己的口服药。口服药被视为这个利润丰厚的GLP-1市场中下一个主要战场。
- 患者可及性：口服剂型可能吸引对注射犹豫的患者。定价旨在与未经批准的复合仿制药竞争。
- 服药注意：必须空腹服用，服药后需等待30分钟才能进食或饮水。
Original Article Link: https://www.cnbc.com/2025/12/22/fda-approves-first-glp-1-pill-for-obesity-from-novo-nordisk.html