CHMP Backs Higher-Dose Wegovy as Novo Nordisk Seeks 2026 EU Approval

Core Insights - Novo Nordisk (NVO) received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the EU approval of a higher dose of its obesity injection, Wegovy (semaglutide), with a final decision expected in early 2026 [1][6] - The regulatory filing seeks approval for a 7.2 mg dose, which is claimed to offer greater weight loss potential compared to existing doses [2][3] - The STEP UP study demonstrated that patients receiving the 7.2 mg dose achieved an average weight loss of 20.7%, significantly higher than the 2.4 mg dose (17.5%) and placebo (2.4%) [3][4] Efficacy and Safety - In the STEP UP study, 33.2% of patients on the 7.2 mg dose achieved at least 25% weight loss at 72 weeks, compared to 16.7% in the 2.4 mg group [4][6] - The safety profile of the higher dose was consistent with the approved 2.4 mg dose, indicating no new safety concerns [5] Regulatory Developments - Novo Nordisk has also applied for a single-dose delivery device for the 7.2 mg Wegovy and submitted a regulatory filing in the U.S. for the same dose, seeking an expedited review through the FDA's CNPV pilot program [7][8] - The CNPV program aims to fast-track the review process for drugs addressing serious medical needs, reducing the standard review period significantly [8] Competitive Landscape - The obesity treatment market is becoming increasingly competitive, with Novo Nordisk and Eli Lilly (LLY) as the primary players [9] - Both companies are racing to introduce oral weight-loss medications, with Novo Nordisk already seeking approval for an oral version of Wegovy [11] - Eli Lilly is also developing a range of next-generation drugs, including orforglipron and retatrutide, with regulatory filings expected soon [12] Emerging Competitors - Smaller biotech firms like Viking Therapeutics and Structure Therapeutics are advancing their own GLP-1-based therapies, potentially challenging the market dominance of Novo Nordisk and Eli Lilly [13][14] - Viking Therapeutics is conducting late-stage studies for its VK2735 candidate, while Structure Therapeutics is preparing for late-stage studies of aleniglipron [13][14] Market Performance - Over the past year, Novo Nordisk's shares have declined by 53.6%, contrasting with the industry's growth of 12.2% [5]