Novo Nordisk Adds NAION Warning to GLP-1 Labels While Lifting Guidance and Naming New CFO
Published on 11/10/2026 at 07:11 | Editorial boerse-global.de
Novo Nordisk investors had two very different pieces of news to digest this week: a regulatory change affecting its flagship GLP-1 franchise and a fresh set of corporate and financial updates. The US Food and Drug Administration has ordered the company to add a warning about a possible increased risk of the eye condition NAION to the US product information for Ozempic and Wegovy. The order, issued yesterday, applies to the entire GLP-1 drug class, and Reuters reports that it also covers Eli Lilly's Mounjaro and Zepbound.
What the Warning Says
The FDA requires the notice to appear in the warnings and precautions section of the labeling. NAION can disrupt the blood supply to the optic nerve and cause sudden, painless vision loss that may be permanent and typically affects one eye. No treatment is known to reverse the loss. The agency advises patients to seek immediate medical help if they experience sudden vision loss, blurred vision or blind spots, and to discuss their medication with a doctor if NAION is diagnosed. It warns against stopping treatment on one's own.
A Large Evidence Base, a Rare Event
The regulator reviewed 126 clinical trials involving more than 134,000 patients and identified a total of 15 probable NAION cases. Among GLP-1 users, the observed frequency was 6.4 cases per 100,000 patient-years, compared with 3.8 cases in the comparison groups. A supplementary FDA review in adults with type-2 diabetes produced mixed results depending on the comparator drug: an increased risk emerged against DPP-4 inhibitors, while the difference versus SGLT-2 inhibitors was not statistically significant. The safety assessment therefore depends in part on which treatment groups are compared.
BMO analysts view the risk to Novo Nordisk and Eli Lilly as limited given how rare the condition is — a view that holds for Novo Nordisk as long as the low frequency is confirmed in further research. The stock rose 1.9% yesterday, holding firm on the day of the FDA order.
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Guidance Raised for the Third Time
The regulatory news came alongside a more upbeat operational picture. On 4 November Novo Nordisk lifted its 2026 outlook for the third time, having previously projected a decline of as much as 6%. It now expects adjusted sales and adjusted operating profit at constant exchange rates to land between a 2% decline and 2% growth, with the new range applying to both metrics.
In the third quarter of 2026, adjusted sales at constant currencies climbed 4% to DKK 79.2 billion, while adjusted operating profit jumped 27% to DKK 31.7 billion. Sales of the Wegovy tablet reached DKK 5.39 billion in the same quarter. The company published those figures together with the upgraded annual forecast.
CFO Change at the Top
Also on 4 November, Novo Nordisk appointed Luigi La Corte as Executive Vice President and Chief Financial Officer. He succeeds Karsten Munk Knudsen, who will leave the company at the end of the year to pursue other opportunities. Reuters also reported Knudsen's impending departure and La Corte's move to Novo Nordisk as the new finance chief; the company statement names year-end as the timing of Knudsen's exit.
Novo Nordisk at a turning point? This analysis reveals what investors need to know now.
Buyback Continues
Separately, Novo Nordisk reported yesterday the repurchase of 890,000 B shares for a total of DKK 243.6 million between 3 and 6 November, the latest purchases under its ongoing program. Since 4 February, the company has bought back roughly 42.6 million B shares for around DKK 11.8 billion.
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