Amgen Pfizer Abortion Pill GSK Readout Newsletter
- what: amgen's Repatha (evolocumab) trial shows a statistically significant reduction in major cardiovascular events.
- Why it Matters: Reinforces the efficacy of PCSK9 inhibitors, potentially leading to wider adoption and improved patient outcomes.
- what's Next: Amgen plans to pursue expanded indications and reimbursement opportunities.
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Amgen’s Repatha Trial Demonstrates Significant Heart Risk Reduction and Other Biotech Updates (October 5, 2023)
Table of Contents
Updated October 5, 2023, 08:38:02 AM ET
Amgen’s Repatha Trial Shows Heart risk reduction
Amgen announced on October 4, 2023, that its cholesterol-lowering injection, Repatha (evolocumab), substantially reduced the risk of a composite outcome of cardiovascular death, heart attack, and stroke in a large-scale, 12,000-patient clinical trial. STAT’s Matt Herper reports this positive data could spur wider use of PCSK9 inhibitors, a class of drugs that have faced challenges with adoption despite proven efficacy.
The trial results, presented at the European Society of Cardiology Congress 2023, demonstrated a 15% relative risk reduction in the primary endpoint, meeting the study’s objectives. This builds on previous evidence supporting repatha’s ability to lower LDL cholesterol and reduce cardiovascular events. The study included patients with established cardiovascular disease.
PCSK9 Inhibitors: A History of Slow Adoption
PCSK9 inhibitors, including Repatha and Sanofi/Regeneron’s Praluent (alirocumab), represent a significant advancement in cholesterol management. They work by blocking the PCSK9 protein, which reduces the liver’s ability to remove LDL cholesterol from the blood. Though, their high cost and complex administration (injection) have hindered widespread use. Circulation published an analysis in 2018 detailing the barriers to PCSK9 inhibitor adoption.
Despite demonstrating superior LDL-cholesterol lowering compared to statins, PCSK9 inhibitors have faced reimbursement challenges from insurers. The new data from the Repatha trial may strengthen the case for broader coverage and access, notably for high-risk patients who haven’t achieved adequate LDL-cholesterol control with statins alone.
NIH launches New Office to Reduce Animal Testing
The National Institutes of Health (NIH) has established a new office dedicated to accelerating the development and implementation of alternatives to animal testing. According to an NIH press release issued october 4, 2023, the Office of alternatives to Animal Testing (OAAT) will coordinate efforts across the agency to promote the “3Rs” – Replacement, Reduction, and Refinement – of animal use in research.
The OAAT will focus on funding research into choice methods, validating these methods, and promoting their adoption by researchers. This initiative reflects growing ethical concerns about animal welfare and a desire to improve the efficiency and relevance of biomedical research. The office will be led by dr. danielle Reed.
Other Biotech News
- Vertex Pharmaceuticals is reportedly nearing a deal to acquire gene-editing company Cytozyme for around $1 billion, according to Fierce Biotech.
- Moderna announced positive preliminary data from its mRNA flu vaccine trial,showing promising immune responses.