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Alirocumab (trade name Praluent) is a human monoclonal antibody PCSK9 inhibitor biopharmaceutical drug approved by the FDA in July 2015 as a second line treatment of hypercholesterolemia for adults whose cholesterol is not controlled by diet and statin treatment. It is also known as REGN727 and SAR236553.

Medical uses

Alirocumab is used as a second line treatment to lower LDL cholesterol for people who have hereditary high cholesterol and people with atherosclerosis who require additional lowering of LDL cholesterol when diet and statin treatment have not worked. It is administered by injection.

Side effects

Side effects that occurred in more than 2% of people treated with in clinical trials and that occurred more frequently than with placebo, included nose and throat irritation, injection site reactions and bruising, flu, urinary tract infection, diarrhea, bronchitis and cough, and muscle pain, soreness, and spasms.

History

It was discovered by Regeneron Pharmaceuticals and is being co-developed with Sanofi. A main competitor in the race to worldwide health authority approval is evolocumab in development by Amgen.

In July 2015, the FDA approved alirocumab as a second line treatment to lower LDL cholesterol for people who have hereditary high cholesterol and people with atherosclerosis who require additional lowering of LDL cholesterol when diet and statin treatment have not worked. This was the first approval of a PCSK9 inhibitor.

Research

A phase 3 trial of statin intolerant patients called ODYSSEY ran for 65 weeks. Results were presented at the 2014 European Society of Cardiology meeting.

A 78-week study of alirocumab in 2341 people taking statins who were at high risk for cardiovascular events and had high LDL cholesterol levels was published in April 2015.

References

1. International Nonproprietary Names for Pharmaceutical Substances (INN), World Health Organization
2. Attention: This template ({{cite pmid}}) is deprecated. To cite the publication identified by PMID 24316621, please use {{cite journal}} with |pmid=24316621 instead.
3. ^ Alirocumab label Label revised, July 2015. Page accessed July 25, 2015
4. ^ FDA. July 24, 2015 FDA Press release: FDA approves Praluent to treat certain patients with high cholesterol
5. "Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: Design and rationale of ODYSSEY ALTERNATIVE, a randomized phase 3 trial". Journal of Clinical Lipidology. 8: 554–61. Nov–Dec 2014. doi:10.1016/j.jacl.2014.09.007. PMID 25499937.
6. "Huge Decreases in LDL Cholesterol With Alirocumab: ODYSSEY".
7. Robinson, Jennifer G.; Farnier, Michel; Krempf, Michel; Bergeron, Jean; Luc, Gérald; Averna, Maurizio; Stroes, Erik S.; Langslet, Gisle; Raal, Frederick J. (April 16, 2015). "Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events". New England Journal of Medicine. 372 (16): 1489–1499. doi:10.1056/NEJMoa1501031. ISSN 0028-4793. PMID 25773378.

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