Novo Nordisk Seeks Extra-Fast Nod From FDA for Higher Dose of Wegovy

Core Insights - Novo Nordisk has submitted a regulatory filing for a higher dose of its obesity drug Wegovy, seeking approval for a 7.2 mg dose which is claimed to offer greater weight loss potential compared to existing doses [1][6] - The company is utilizing the FDA's Commissioner's National Priority Voucher pilot program for an expedited review process, potentially reducing the review period to 1-2 months [2] - Data from the phase III STEP UP study supports the filing, showing an average weight loss of 20.7% for participants on the 7.2 mg dose over 72 weeks [3][6] Regulatory Developments - The filing for the 7.2 mg dose is also under review by the EMA, with a final decision expected in Q1 2026 [4] - Novo Nordisk's investigational oral obesity pill, amycretin, has shown significant weight loss and HbA1c reduction in type 2 diabetes, while two studies on Rybelsus did not show superiority in Alzheimer's disease [8] Market Context - The obesity market in the U.S. is projected to reach $100 billion by 2030, with Novo Nordisk and Eli Lilly currently leading the market [11] - Competition is intensifying as both companies are racing to introduce oral weight-loss pills, with Novo Nordisk having submitted a regulatory filing for an oral version of Wegovy [12] Competitive Landscape - Eli Lilly is also developing next-generation drugs, including orforglipron and retatrutide, and has secured a CNPV for orforglipron [13] - Other companies, such as Viking Therapeutics, are advancing their obesity candidates, with ongoing late-stage studies [14][15] - Pfizer has recently acquired Metsera for approximately $10 billion, re-entering the obesity market with new clinical-stage programs [16] Stock Performance - Year to date, Novo Nordisk's shares have decreased by over 43%, contrasting with the industry's growth of 19% [5]