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Results from the Phase III FOURIER trial in high-risk patients with atherosclerotic cardiovascular disease (ASCVD) find that Repatha treatment results in significant reductions in rates of stroke and myocardial infarction. These positive results have excited physicians, although it is likely that reimbursement will remain strict since payers did not view the results as positively as physicians.


The highly anticipated results from the FOURIER cardiovascular outcomes trial (CVOT) of Repatha (evolocumab; Amgen/Astellas) have headlined the 2017 American College of Cardiology (ACC) meetings in Washington DC. In the trial, Repatha was shown to decrease the absolute risk of combined three-point major adverse cardiovascular events (MACE; cardiovascular death, myocardial infarction, or stroke) by 1.5% in the high-risk patient population (rate of events in the Repatha arm was 5.9% versus 7.4% in the placebo arm). This significant decrease in MACE excited physicians attending the conference and will likely increase demand for the medication. However, securing reimbursement of the drug may continue to be difficult as payers interviewed by Datamonitor Healthcare prior to the ACC meeting signaled that they were looking for a larger decrease in events (a 2–3% reduction in absolute risk) in order to justify the high cost of Repatha.


The FOURIER trial was a Phase III multinational, randomized, double-blind, placebo-controlled trial, designed to evaluate whether treatment with Repatha in combination with statin therapy reduces cardiovascular events compared with statin therapy alone. The trial enrolled high-risk patients who exhibited high cholesterol (low-density lipoprotein cholesterol ≥70mg/dL or non-high-density lipoprotein cholesterol ≥100mg/dL) and clinically evident ASCVD. In all, 27,563 patients were randomized into the two treatment arms of the trial, with 13,780 patients receiving Repatha plus effective statin dose and 13,784 patients receiving placebo plus effective statin dose. The median follow-up for the trial was 26 months.


Physicians attending the conference were excited by the significant reductions in rates of stroke and myocardial infarction observed in the FOURIER trial. Reductions in these events were viewed as clinically significant and will likely lead to an increase in physician demand for Repatha. Multiple physicians outlined to Datamonitor Healthcare that the significant reduction in MACE should merit a change in the treatment guidelines to incorporate the use of Repatha into the treatment of high-risk patients. In addition to guideline revisions, attendees also mentioned that it is likely the data from this CVOT will be incorporated into the label for Repatha. The addition of these positive CVOT data on Repatha’s label will likely also increase demand for the medication.


However, results from the trial seemed to fall short of payer expectations and as a result it is likely that payers will continue to restrict access to the expensive medication. In interviews with payers prior to the conference, Datamonitor Healthcare gathered that payers were looking for an absolute risk reduction of 2–3% from the trial in order to justify paying $14,000 a year for the drug. From the payer perspective, it is unlikely that the 1.5% risk reduction observed in the FOURIER trial will be enough to justify the high cost of Repatha. This will likely result in the continuation of restricted reimbursement of the drug, hampering its uptake.


The CVOT data from the ODYSSEY clinical trial program of competitor proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Praluent (alirocumab; Sanofi/Regeneron) are expected to be available in the first half of 2018. Physician sentiment gathered by Datamonitor Healthcare at the ACC meetings is that Repatha and Praluent are viewed as equivalent by prescribers and as a result the FOURIER trial data should increase demand for both medications. However, if the results of the ODYSSEY OUTCOMES trial differ significantly from those observed in the FOURIER trial, it is possible that physicians may begin to favor one medication over the other.


Opinion piece 2: Praluent US sales block gives advantage to Amgen's Repatha in dyslipidemia


On 5 January, Amgen secured a court ruling blocking Praluent (alirocumab; Sanofi/Regeneron) from being sold in the US. This ruling clears the way for Amgen’s Repatha (evolocumab) to potentially become the sole proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in the US market. The imposition of the order will be delayed by 30 days, during which time Sanofi is expected to appeal the decision to the US Federal Circuit Court of Appeals, although the negotiation of a settlement is another potential option.


Amgen’s win over Sanofi and Regeneron came after a US district judge refused to overturn a verdict from March 2016, upholding Amgen’s patents related to the PCSK9 protein. However, the judge’s decision to ban Regeneron and Sanofi from selling Praluent in the US, as a penalty for infringing on Amgen’s patent, came as a surprise to many. Most experts anticipated that Regeneron and Sanofi would be asked to pay royalties to Amgen, but the judge determined that Regeneron and Sanofi had “demonstrated irreparable harm” to Amgen, and that monetary compensation would be inadequate.


This decision is a major victory for Amgen in a potentially lucrative market. Repatha and Praluent are currently forecast to each earn more than $2bn in annual revenue in the US by 2024 (see Datamonitor Healthcare’s Forecast: Dyslipidemia). Failure to reverse the ban on Praluent in the US would likely result in Repatha gaining the majority of Praluent’s expected revenue, potentially doubling Repatha’s value. However, it is important to keep in mind that PCSK9 inhibitor sales to date have been disappointing, primarily due to insurance companies’ refusal to provide reimbursement. These drugs reduce low-density lipoprotein cholesterol to previously unattainable levels, but lack data on their ability to reduce the rates of heart attacks, strokes, and death. Data from a cardiovascular outcomes trial for Repatha are expected in Q1 2017, and will provide more information on the clinical outcomes associated with PCSK9 inhibitors. A positive result will spur uptake of the PCSK9 class, and likely allow it to attain its forecasted revenue.

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