What's Happening?
At the American Heart Association's 2025 Scientific Sessions in New Orleans, major pharmaceutical companies including Amgen, Merck, and Novo Nordisk showcased significant advancements in cardiovascular treatments. Amgen presented data from its Phase III
VESALIUS-CV trial, highlighting the efficacy of its lipid-lowering antibody Repatha in reducing cardiovascular risk by 25% among patients with atherosclerotic cardiovascular disease or high-risk diabetes. Merck revealed promising results from its Phase III trial of enlicitide decanoate, an oral PCSK9 inhibitor, which demonstrated a 55.8% reduction in LDL-C levels. Novo Nordisk shared mixed results from its Phase II study of coramitug, an investigational antibody for ATTR-CM, showing significant biomarker reduction at a specific dose. Intellia Therapeutics reported long-term efficacy of its CRISPR-based gene therapy nex-z, despite a recent patient death leading to an FDA clinical hold.
Why It's Important?
These developments represent significant strides in the treatment of cardiovascular diseases, potentially altering current medical practices. Amgen's Repatha could redefine cardiometabolic risk management, while Merck's enlicitide decanoate may become the first oral PCSK9 inhibitor, offering a more convenient option compared to injectables. Novo Nordisk's coramitug could introduce a new mode of action for ATTR-CM patients, despite mixed results. Intellia's CRISPR-based therapy highlights the promise and challenges of gene editing in medicine. These innovations could lead to improved patient outcomes, reduced healthcare costs, and expanded treatment options, impacting millions of Americans affected by cardiovascular conditions.
What's Next?
Amgen aims to update Repatha's label to reflect new data, potentially broadening its use. Merck plans to discuss enlicitide's findings with global regulatory authorities, which could lead to its approval as the first oral PCSK9 inhibitor. Novo Nordisk intends to advance coramitug into Phase III trials, despite mixed Phase II results. Intellia is working with the FDA to address the clinical hold on its gene therapy trials. These steps could lead to new treatment approvals and expanded indications, influencing future cardiovascular disease management.
Beyond the Headlines
The advancements presented at AHA 2025 highlight the growing role of precision medicine and genetic therapies in cardiovascular care. Ethical considerations around gene editing, such as those raised by Intellia's patient death, underscore the need for careful regulatory oversight. The shift towards oral medications, like Merck's enlicitide, reflects a broader trend towards patient-friendly treatment options. These developments may also drive further research into personalized medicine, potentially transforming the landscape of cardiovascular treatment.
