DENMARK—Novo Nordisk has said the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on modifying the Wegovy® (semaglutide 2.4 mg) label in the European Union (EU).
This update includes data demonstrating that Wegovy, when used alongside standard care, can significantly reduce heart failure symptoms and improve physical limitations and exercise capacity in individuals with obesity-related heart failure with preserved ejection fraction (HFpEF), regardless of whether they have type 2 diabetes.
This recommendation is based on the results of the STEP HFpEF and STEP HFpEF-DM clinical trials, which involved participants with obesity-related HFpEF, with and without type 2 diabetes.
Both trials showed that Wegovy was more effective than a placebo in reducing heart failure symptoms and improving physical function, as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).
In addition to these benefits, participants on Wegovy also experienced greater weight loss compared to those on a placebo.
Novo Nordisk highlighted that Wegovy’s positive effects were observed across diverse patient groups, irrespective of factors such as age, sex, race, ethnicity, body mass index (BMI), region, systolic blood pressure, left ventricular ejection fraction, or concurrent heart failure treatments.
The label update also includes findings indicating that individuals treated with Wegovy demonstrated more significant improvements in exercise capacity, as assessed by the six-minute walking distance (6MWD) test, from baseline to week 52, compared to those who received a placebo.
Commenting on this update, Martin Holst Lange, Executive Vice President and Head of Development at Novo Nordisk, emphasised that it represents a crucial milestone for individuals with obesity-related HFpEF, a population with limited treatment options.
He noted that Wegovy not only improves the quality of life for these patients but also enhances their ability to perform daily activities.
Lange further stated that these findings boost the growing body of evidence supporting the benefits of semaglutide.
This new data from the STEP HFpEF trials complements a recent EMA label update for Wegovy, which now incorporates findings from the SELECT trial, showcasing the drug’s ability to lower the risk of heart attack, stroke, and cardiovascular death.
Following this positive opinion from the CHMP, Novo Nordisk expects the EU label update to be implemented soon, pending a linguistic review by the EMA.
The company also plans to resubmit the STEP HFpEF trial data to the US Food and Drug Administration (FDA) in 2025 for potential inclusion in the Wegovy label in the United States.
Novo Nordisk expands genetic medicine portfolio with NanoVation partnership
In a separate development, Novo Nordisk has signed a US$600 million partnership with NanoVation to advance the development of genetic medicines for rare and cardiometabolic disorders.
This multi-year agreement includes an undisclosed upfront payment, research funding, and potential milestone payments. NanoVation is also set to receive tiered royalties on future product sales.
As part of the agreement, Novo Nordisk will gain access to NanoVation’s long-circulating lipid nanoparticle (lcLNP) technology, which is designed for RNA delivery to cells outside the liver.
Both companies will collaborate on two initial programs aimed at developing base-editing therapies for rare genetic disorders, with plans to target up to five more indications for cardiometabolic and other rare diseases.
This partnership aligns with Novo Nordisk’s broader strategy to solidify its leadership in the cardiometabolic disease space.
Over the past few years, Novo has established several key partnerships, including collaborations with US biotech firms Omega Therapeutics and Cellarity in January and an agreement with Neomorph in February 2024 to discover molecular glue degraders for treating cardiometabolic and rare diseases, according to Pharmaceutical Technology.
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