From the Guidelines
The patent revocation of Repatha (Evolocumab) in Europe is likely to increase accessibility and reduce costs for patients with high cholesterol who require PCSK9 inhibitors, as evidenced by the potential entry of generic versions into the market 1. The impact of the patent revocation on Repatha (Evolocumab) is significant, as it may lead to increased competition and lower costs for patients. Repatha is a crucial medication for patients with high cholesterol who do not respond adequately to statins, as it has been shown to reduce LDL cholesterol levels by 59% in patients with prior ASCVD and high-risk features 1. Key points to consider:
- The FOURIER trial demonstrated the efficacy of evolocumab in reducing LDL cholesterol levels and improving ASCVD outcomes in high-risk patients 1.
- The patent revocation in Europe may lead to the entry of generic versions of Repatha, increasing accessibility and reducing costs for patients.
- In the United States, Repatha's patents remain valid until later dates, with key patents extending into the mid-2020s. The effects of PCSK9 inhibition on ASCVD outcomes, as investigated in the FOURIER trial, highlight the importance of Repatha as a treatment option for patients with high cholesterol who require additional lowering of LDL cholesterol beyond statin therapy 1. Overall, the patent revocation of Repatha (Evolocumab) is likely to have a positive impact on patient accessibility and healthcare costs, particularly in Europe, where generic versions may enter the market earlier than expected.
From the Research
Impact of Patent Revocation on Repatha (Evolocumab)
- The patent revocation of Repatha (Evolocumab) may lead to increased competition in the market, potentially resulting in lower prices for the medication 2.
- Evolocumab has been shown to significantly reduce low-density lipoprotein cholesterol (LDL-C) levels, with reductions of 50-60% observed in clinical trials 3, 2, 4.
- The medication has also been demonstrated to reduce the risk of cardiovascular events, including myocardial infarction and stroke, in patients with established cardiovascular disease 3, 4, 5.
- However, the high cost of evolocumab has been a significant barrier to its adoption, and the patent revocation may help to increase access to the medication for patients who need it 2, 4.
- The European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) guidelines recommend the use of PCSK9 inhibitors, including evolocumab, for the treatment of very high-risk patients who are not achieving treatment goals on a maximum tolerated dose of a statin and ezetimibe 3.
Clinical Evidence
- Multiple clinical trials have demonstrated the efficacy and safety of evolocumab in reducing LDL-C levels and cardiovascular risk 6, 3, 2, 4, 5.
- The FOURIER and ODYSSEY outcome trials have provided significant evidence for the clinical benefit of evolocumab in reducing cardiovascular events 3, 4.
- A systematic review of 24 studies, including 18 trials of alirocumab and 6 trials of evolocumab, found that PCSK9 inhibitors reduced the risk of cardiovascular events, including myocardial infarction and stroke, compared to placebo or active treatment 5.
Market Implications
- The patent revocation of Repatha (Evolocumab) may lead to the entry of biosimilar products into the market, potentially increasing competition and reducing prices 2.
- The increased availability of evolocumab and other PCSK9 inhibitors may lead to increased adoption of these medications for the treatment of high-risk patients 3, 4.