Fresh Safety Concerns for Amgen’s Repatha Raises Alarm: Reanalysis of Key Trial Flags Troubling Results

The FOURIER trial recently revealed that Amgen’s injectable cholesterol therapeutic, Repatha (evolocumab), may lead to an increased risk of cardiovascular death. This finding was revealed through a reanalysis of the trial’s data, prompting further investigation into the potential implications of this drug on cardiovascular health.

The researchers, writing in the open access journal BMJ Open, have identified a number of concerning discrepancies between the 2017 New England Journal of Medicine publication of FOURIER’s primary results and its Clinical Study Report (CSR), a technical document containing far more comprehensive data on the trial. These ‚Äúsignificant inconsistencies and misreporting‚ÄĚ are worrying, raising questions about the reliability of the results.

In the Clinical Study Report (CSR), the number of Repatha-treated patients who died from myocardial infarction was alarmingly higher than that reported in the 2017 NEJM paper, with 36 fatalities instead of 25. Even more concerning, the number of cardiac failure deaths identified in the CSR was nearly double what was reported, at 31.

In contrast to the 2017 publication, the CSR revealed three fewer deaths among those taking the placebo.

The 2017 NEJM publication revealed that evolocumab could reduce the risk of non-fatal myocardial infarctions and strokes. However, a subsequent readjudication of the FOURIER data pointed to a higher number of cardiovascular deaths than what had been initially reported.

The researchers were surprised to find that cardiovascular mortality had increased with the use of evolocumab, despite a decrease in myocardial infarctions and strokes – two of the leading causes of cardiovascular deaths.

The FOURIER trial was the driving force behind Repatha’s regulatory approval in 2015, providing key evidence that allowed the groundbreaking medication to reach the market.

Repatha is a biologic designed to help reduce LDL cholesterol levels in the blood. It works by binding to PCKS9, a protein that usually breaks down receptors for low-density lipoprotein cholesterol on the surfaces of liver cells. By blocking the action of PCKS9, Repatha helps the body clear LDL cholesterol from the blood, leading to improved cholesterol levels.

Accurate assessment of Repatha is critical, for it is the first of its kind – the first drug in a brand new drug class. The authors of the BMJ article identified inconsistencies in the findings, indicating that a full restoration of clinical outcomes from the FOURIER trial is needed.

Amgen Takes Repatha Patent Fight to Supreme Court

Last week, biotech giant Amgen threw down the gauntlet, filing a Supreme Court brief in a bid to protect its blockbuster drug Repatha and block the sale of rival PCSK9 inhibitor Praluent, developed by Sanofi and Regeneron. Amgen’s argument is sure to set the stage for a thrilling legal battle between two of the industry’s biggest players.

Amgen took swift legal action against Sanofi and Regeneron in 2014 when the two partners sought to gain FDA approval for Praluent. After two separate jury trials, Amgen was triumphant, as their patents were deemed both valid and legally binding.

The U.S. Court of Appeals for the Federal Circuit ruled against two patent decisions, asserting that the patents were not valid due to a lack of sufficient information that would enable someone in the field to reproduce the antibodies without excessive trial and error. The decision overturned the original decisions, allowing others to pursue the same research without violating patent law.

Amgen has taken its case to the Supreme Court, and a verdict is anticipated by the middle of the year, as reported by Reuters. It remains to be seen what fate awaits the company, as the highest court in the land makes its ruling.

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