European Drug Agency Supports Novo Nordisk's Blockbuster Weight-Loss Drug Wegovy For Obesity-Related Heart Failure

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of Novo Nordisk A/S’ NVO Wegovy (semaglutide 2.4 mg) label.

The label update incorporates data showing that Wegovy, when added to the standard of care, can reduce heart failure-related symptoms and improve physical limitations and exercise function in people with obesity-related HFpEF, with or without type 2 diabetes.

Also Read: Ozempic Maker Novo Nordisk Touts Encouraging Data From New Obesity Pill Showing Double Weight Loss Compared To Wegovy

Heart failure affects at least 64 million people worldwide and is especially prevalent in obese and/or type 2 diabetes patients.

Heart failure with preserved ejection fraction (HFpEF) is now the most common form of heart failure, comprising approximately 50% of all heart failure cases.

The positive opinion is based on the results from the STEP HFpEF and STEP HFpEF-DM trials.

In both trials, Wegovy demonstrated greater reductions in heart failure-related symptoms, improvements in physical limitations, and weight loss compared to placebo.

The label update also incorporates data that showed that participants receiving Wegovy achieved a greater increase in exercise function, as measured by the difference in 6-minute walking distance (6MWD) from baseline to week 52, compared to those receiving placebo.

The recommendation to incorporate the data from the STEP HFpEF trials adds to the recent Wegovy EMA label update, which included data from the SELECT landmark trial to reflect the risk reduction of heart attack, stroke, and cardiovascular death.

With the positive opinion from the CHMP, Novo Nordisk expects implementation of the EU label update shortly, following a linguistic review process by the EMA.

As communicated earlier this year, Novo Nordisk will resubmit to the FDA in 2025 to include data from the STEP HFpEF trials in the Wegovy label in the U.S.

In its quarterly earnings report, Novo Nordisk announced that it had submitted the Wegovy STEP HFpEF trials data for regulatory review in the U.S. and EU in January 2024. However, following discussions with the FDA, the company withdrew the submission.

Novo Nordisk said it plans to resubmit the file in early 2025, incorporating additional data, including findings from the kidney outcomes trial for its once-weekly injectable semaglutide 1.0 mg.

Price Action: NVO stock is down 0.42% at $134.32 during the premarket session at last check Friday.

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