Novo Nordisk Wins European Approval for FREHEMGO as U.S. Warning Affects GLP-1 Drugs

Key Facts

Novo Nordisk said on November 13, 2026, that FREHEMGO had received European marketing approval to treat hemophilia A, expanding the company’s portfolio beyond diabetes and obesity drugs. The announcement came four days after the U.S. Food and Drug Administration said holders of licenses for all GLP-1 drugs must add information on a possible increased risk of non-arteritic anterior ischemic optic neuropathy to the warnings and precautions section. The agency cited Ozempic and Wegovy among the drugs. The company’s shares, listed under the ticker NVO, closed at $41.63 on November 13, according to EL7 data. The timing links a positive regulatory development for the company in hemophilia treatment with a U.S. safety warning concerning a broad class of its products.

The FDA warning focuses on NAION, a rare condition that can cause a sudden, painless loss of vision in one eye and may lead to permanent blindness. The agency said information about this potential risk must be added to the labels of all GLP-1 drugs, making the action class-wide rather than specific to a single drug. It named Ozempic and Wegovy among the drugs concerned. The agency issued its statement on November 9, 2026, four days before the European approval announcement. The U.S. warning therefore remains separate in timing and regulatory terms from the European Commission’s decision on FREHEMGO.

The FDA’s analysis of randomized controlled trials was based on 126 trials involving 134,253 patients. The rate of observed NAION cases among users of GLP-1 drugs was about 6.4 cases per 100,000 patient-years, compared with 3.8 cases per 100,000 patient-years in the comparison group. These rates show that observed cases were few relative to the number of patients and duration of follow-up, despite the higher rate in the GLP-1 group in the analysis. The agency presented these findings in connection with its decision on the label updates. An Associated Press review of the analysis described it as covering more than 125 trials, with an approximate rate of 6 cases per 100,000 among people who had taken the drug for at least a year, versus fewer than 4 in the comparison group.

In an FDA observational study of patients with Type 2 diabetes between 2019 and 2024, the agency found no statistically significant increase in NAION risk when GLP-1 drugs were compared with SGLT-2 inhibitors. The hazard ratio in that comparison was 1.19, with a confidence interval of 0.91 to 1.54. By contrast, the study found an increase compared with DPP-4 inhibitors, with a hazard ratio of 1.43 and a confidence interval of 1.02 to 2.01. These findings put the treatment comparisons in a different context from the pooled rate in randomized trials. They show that the estimated risk varied according to the comparison group, as the FDA reported in its review of the data.

On the company’s business, Novo said in its financial report issued on November 4 that adjusted sales rose 4% at constant exchange rates in the third quarter of 2026. The company attributed the increase to continued growth in GLP-1 drug volumes in the U.S. and international operations, particularly obesity drugs. This places the safety warning in a period when the company reported sales growth in the class that includes Ozempic and Wegovy. The financial data show that volume growth was a stated driver of sales in the quarter. The new European approval, meanwhile, concerns FREHEMGO and hemophilia A treatment, not GLP-1 drugs.

In the United States, Novo said in its financial report that regulatory review of denecimig was still underway. It added that launch there was expected in the first half of 2027, subject to a regulatory decision. This sets out the anticipated U.S. pathway for the drug, while the November 13 announcement concerns European approval for FREHEMGO. The regulatory decision requirement means the expected launch timing is not a confirmed marketing date. The next development identified by the company therefore remains the outcome of the U.S. review on the path to the first half of 2027.