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Evolocumab
Pharmaceutical drug From Wikipedia, the free encyclopedia
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Evolocumab,[6] sold under the brand name Repatha, is a monoclonal antibody that is an immunotherapy medication for the treatment of hyperlipidemia.
Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that targets LDL receptors for degradation; its inhibition thereby enhances the liver's ability to remove LDL-C, often colloquially referred to as "bad" cholesterol, from the blood.[7][8]
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Mechanism
Evolocumab is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of liver cells to remove LDL-C from the blood.[9]
Adverse effects
Injection site reactions such as redness and pain are common and are reported in approximately 2.1–4.3% of cases.[10][11] A reanalysis of the FOURIER trial based on regulatory data found that cardiac mortality with evolocumab was slightly higher than previously reported, however, this remained statistically insignificant.[12] Moreover, a follow up study over 5 years (FOURIER-OLE) showed that cardiovascular death was in fact reduced with evolocumab.[13]
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History
Summarize
Perspective
Amgen submitted a biologics license application (BLA) for evolocumab to the FDA in August 2014.[14] The FDA approved evolocumab injection on 27 August 2015, for some patients who are unable to get their LDL cholesterol under control with current treatment options.[15] The European Commission approved it in July 2015.[16] Evolocumab received approval from Health Canada on 10 September 2015.[17] Amgen reported approval by Health Canada in a press release on 15 September 2015.[18]
Results of the FOURIER trial were published in March 2017.[19]
Regeneron Pharmaceuticals and Amgen each filed for patent protection on their monoclonal antibodies against PCSK9 and the companies ended up in patent litigation in the U.S. In March 2016, a district court found that Regeneron's drug alirocumab infringed Amgen's patents; Amgen then requested an injunction barring Regeneron and Sanofi from marketing alirocumab, which was granted in January 2017. The judge gave Regeneron and Sanofi 30 days to appeal before the injunction went into effect.[20] After several years of litigation, the patent dispute between Regeneron and Amgen was docketed by the SCOTUS for March-April 2023[21] Numerous legal commentators were surprised by the SCOTUS decision, considering the existing trend not to review patent cases from the United States Court of Appeals for the Federal Circuit, since this court was created in 1982 to assure uniformity in patent law among all federal courts. The question before the US Supreme Court was "Whether enablement is governed by the statutory requirement, that the specification teach those skilled in the art to “make and use” the claimed invention, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “time and effort".[21] Other commentators believe that the SCOTUS took the case because of the significance of the legal question, which was deemed comparable to the impact of KSR v. Teleflex.
Amgen's issued patents contained a so-called “functional genus claim,” which defines an antibody by its epitope, the specific target against which it binds. Although Amgen did discover the target antigen, the antigen itself cannot be patented, because it is a product of nature (i.e. it was discovered rather than invented). However, Amgen was able to convince the USPTO to issue a patent that broadly claimed yet-unmade antibodies with a high affinity to the discovered antigen. Although there are many potential problems with such "functional genus" claims, the lower courts invalidated Amgen's broad claims based on the patent requirements for sufficiency of disclosure. The purposivism justification for disallowing such broad poorly-enabled claims is to allow other pharmaceutical companies to develop other (and potentially better) drugs that target the same antigen. However, the drawback of such narrow interpretation is the resulting reluctance of the antigen discoverers to share their findings with the world, because such early disclosure would prevent them from reaping the maximum profits from their discovery, which they could obtain by developing multiple medications and keeping them secret for many years. [22] Such a dilemma is not unique to biologics or to pharmaceuticals, since the purpose of the patent system is to provide an incentive for earlier disclosure in the gambling game from discovery to market, that does not necessarily reward every participant according to their contribution, but encourages discoverers and inventors to play the gambling game nevertheless.[23]
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Society and culture
Economics
In 2015, evolocumab cost about US$14,100 per year. One article calculated this to be about $400,000 to $500,000 per quality-adjusted life year (QALY), which did not meet "generally accepted" cost-benefit thresholds. The authors calculated that an annual cost of $4,500 would meet an acceptable $100,000 per QALY standard.[24] On 26 October 2018, Amgen announced a 60% cut in price, setting the new price at $5,850 per year.[25]
In Australia, as of April 2025, evolocumab has been added to the Pharmaceutical Benefits Scheme (PBS) and is subsidized for qualified patients. The cost to the PBS is AUD$339.25 for 2 injectable pens (enough for 4 weeks use = AUD$4420/yr), and the cost to the patient is AUD$31.60 (AUD$416/yr) [26]
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References
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