Novo Nordisk Secures EU CHMP Backing for Ozempic® Label Expansion in PAD, Reinforcing Semaglutide’s Role in Managing Type 2 Diabetes with Comorbidities
Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion supporting a label update for its once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA), Ozempic® (semaglutide). This update is based on robust findings from the STRIDE trial, a landmark study examining the drug’s efficacy in peripheral artery disease (PAD)—a common, debilitating, and often overlooked complication in individuals with type 2 diabetes (T2D).
A Milestone for Ozempic®: Addressing PAD in Type 2 Diabetes
PAD is a manifestation of atherosclerotic cardiovascular disease (ASCVD), where narrowed arteries reduce blood flow to the limbs, especially the legs. This condition significantly affects patients’ mobility and quality of life, often leading to pain, reduced walking capacity, and, in severe cases, limb amputation. While PAD is prevalent among those with type 2 diabetes, dedicated treatments targeting functional outcomes in PAD have been notably absent—until now.
The STRIDE study stands out as the only functional outcomes trial in PAD conducted with a GLP-1 RA, underscoring Novo Nordisk’s commitment to deepening the therapeutic impact of semaglutide. According to the company, the findings from STRIDE demonstrated that once-weekly semaglutide 1.0 mg significantly improved patients’ walking distance, regardless of other diabetic characteristics, thereby offering a meaningful enhancement in day-to-day life for this patient population.
Comprehensive Cardiometabolic Management with Ozempic®
Ludovic Helfgott, Executive Vice President of Product & Portfolio Strategy at Novo Nordisk, emphasized the broader implications of the label update. He stated,
“People living with type 2 diabetes face multiple cardiometabolic challenges, yet there is a lack of treatments that address the full disease spectrum. Pending a decision from the European Commission, a STRIDE label update would complete the picture for Ozempic®, making it the only GLP-1 RA to have proven risk reduction of cardiovascular death, heart attack, stroke, major kidney events, and improvement in functional walking capacity in people with type 2 diabetes.”
If approved by the European Commission—a decision expected within approximately two months—this label expansion will further solidify Ozempic® as a foundational therapy for people living with type 2 diabetes complicated by comorbid cardiovascular, kidney, and peripheral artery diseases.
Label Expansion Also Underway in the U.S.
Novo Nordisk is not limiting its ambitions to Europe. The company has also submitted a similar label expansion request to the U.S. Food and Drug Administration (FDA), with a regulatory decision anticipated in Q4 2025. If approved, this would bring Ozempic®’s benefits in PAD to a much broader global population.
Additionally, the company is working to enhance the positioning of its oral semaglutide formulation, Rybelsus®, with label expansion filings submitted to both the EMA and FDA. These are based on positive data from the SOUL trial, which demonstrated cardiovascular (CV) benefits of Rybelsus® in patients with type 2 diabetes. If approved, Rybelsus® would become the first and only oral GLP-1 RA with demonstrated CV benefits—a significant milestone in diabetes treatment.
ADA 2024: Data from Semaglutide Clinical Trials Strengthen Evidence Base
At the 85th Scientific Sessions of the American Diabetes Association (ADA), Novo Nordisk showcased secondary analyses from the STRIDE, SOUL, and FLOW trials, further bolstering the case for semaglutide across a spectrum of comorbid conditions.
- STRIDE Trial: The results highlighted that semaglutide significantly improved walking distance in PAD patients, regardless of their baseline characteristics. This finding is especially relevant given the lack of treatment options that improve physical function in PAD.
- SOUL Trial: Findings indicated that the cardiovascular benefits of oral semaglutide were more pronounced in individuals with higher HbA1c levels, suggesting the drug’s effectiveness even in patients with poorly controlled blood sugar levels. Importantly, CV benefits were found to be consistent across different body mass index (BMI) categories.
- FLOW Trial: The study focused on chronic kidney disease (CKD) in type 2 diabetes patients. Secondary data showed that semaglutide’s kidney-protective effects were independent of weight loss, confirming its direct renal benefits. Moreover, economic analyses projected that adding semaglutide to the standard of care would be highly cost-effective over the long term, at least within the Danish healthcare system.
These secondary data are crucial not only for regulatory submissions but also for informing clinical practice. They offer a multi-dimensional understanding of how semaglutide performs across comorbid conditions and patient subgroups—information that is invaluable for individualized patient care.
A Broader Therapeutic Landscape for Semaglutide
Semaglutide’s expanding clinical portfolio now includes benefits in multiple disease areas beyond glucose lowering:
- Type 2 Diabetes and Cardiovascular Risk Reduction
- Chronic Kidney Disease (CKD)
- Peripheral Artery Disease (PAD)
- Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Obesity
- Heart Failure with Preserved Ejection Fraction (HFpEF), both with and without type 2 diabetes
These applications reflect the evolution of semaglutide into a multi-indication, system-wide therapy, well-aligned with the complex, interwoven nature of metabolic diseases.
Since its launch in 2018, semaglutide has been prescribed extensively, amassing more than 33 million patient-years of exposure across indications. Its safety profile remains robust, supporting continued confidence among prescribers and patients.
Implications for Clinical Practice and Market Position
Should the European Commission endorse the CHMP’s recommendation, this will position Ozempic® as the most comprehensively indicated GLP-1 RA available in the region. It would not only demonstrate efficacy in traditional endpoints like blood glucose control and cardiovascular risk reduction but also in functional outcomes that matter deeply to patients—such as the ability to walk further without discomfort or pain.
The STRIDE update has potential ramifications for clinical guidelines, which may increasingly view GLP-1 RAs like Ozempic® as first-line or early-intervention options in patients with PAD or other comorbidities. It also strengthens Novo Nordisk’s strategic leadership in the GLP-1 space—a category that continues to see increasing competition, particularly in the growing obesity and cardiometabolic markets.
A Transformative Step for Patients and Providers
The CHMP’s positive opinion on Ozempic® in PAD is not merely a regulatory milestone—it represents a paradigm shift in how clinicians can approach the treatment of type 2 diabetes and its wide-ranging complications. With proven efficacy across cardiovascular, renal, metabolic, and now functional endpoints, semaglutide is shaping up to be the backbone therapy for cardiometabolic health.
As healthcare systems worldwide grapple with the burden of chronic metabolic diseases, semaglutide’s emerging versatility provides a hopeful narrative: one in which a single therapy can address multiple, interconnected conditions—offering better outcomes, improved quality of life, and long-term value for patients and society alike.
