Evolocumab, sold under the brand nameRepatha, is a medication used to treatabnormal lipids and preventheart disease.^[3] It is less preferred tostatins.^[3] It is given by injection under the skin every 2 weeks or once a month.^[3]

Common side effects include runny nose,upper respiratory tract infection, back pain, and pain at the site of injection.^[2] Other side effects may includeallergic reactions.^[3] Safety in pregnancy is unclear.^[3] It is amonoclonal antibody that attaches to and blocksproprotein convertase subtilisin/kexin type 9 (PCSK9).^[2]

Evolocumab was approved for medical use in the United States and Europe in 2015.^[3][2] In the United Kingdom it costs theNHS about £340 every 4 weeks as of 2021.^[4] This amount in the United States is about 470 USD.^[6]

Medical uses

Dosage

It is used at a dose of 140 mg every two weeks or 420 mg once a month.^[2]

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.^[8]

PCSK9 is a protein that targetsLDL receptors for degradation and its inhibition thereby enhances the liver's ability to removeLDL-C, or "bad"cholesterol, from the blood.^[9]

History

Amgen submitted abiologics license application (BLA) for evolocumab to theFDA in August 2014.^[10] 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.^[11] The European Commission approved it in July 2015.^[12] Evolocumab received approval from Health Canada on September 10, 2015.^[13] Amgen reported approval by Health Canada in a press release on September 15, 2015.^[14]

Regeneron Pharmaceuticals and Amgen had each filed for patent protection on their monoclonal antibodies against PCSK9 and the companies ended up inpatent litigation in the U.S. In March 2016 a district court found that Regeneron's drugalirocumab infringed Amgen's patents; Amgen then requested aninjunction 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.^[15]

Results of the FOURIER trial were published in March 2017.^[16]

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 perquality-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.^[17] It is made byAmgen. On October 26, 2018 Amgen announced a 60% cut in price and the drug now costs $5,850 per year.^[18]

References

External links

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