Evolocumab (trade name Repatha) is a
monoclonal antibody
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell.
Monoclonal antibodies ...
medication designed 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 and its inhibition thereby enhances the liver's ability to remove
LDL-C, or "bad"
cholesterol, from the blood.
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.
History
Amgen submitted a
biologics license application
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is respo ...
(BLA) for evolocumab to the
FDA in August 2014. 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.
The European Commission approved it in July 2015. Evolocumab received approval from Health Canada on September 10, 2015. Amgen reported approval by Health Canada in a press release on September 15, 2015.
Regeneron Pharmaceuticals and Amgen had 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.
Results of the FOURIER trial were published in March 2017.
Society and culture
Economics
In 2015 it 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. On October 26, 2018 the maker of the drug,
Amgen
Amgen Inc. (formerly Applied Molecular Genetics Inc.) is an American multinational biopharmaceutical company headquartered in Thousand Oaks, California. One of the world's largest independent biotechnology companies, Amgen was established in ...
, announced a 60% cut in price and the drug now costs $5,850 per year.
References
External links
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PCSK9 inhibitors
Monoclonal antibodies