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A phase 3 trial of statin intolerant patients called ODYSSEY ran for 65 weeks.<ref>{{Cite journal|url = |title = 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.|last = |first = |date = Nov–Dec 2014|journal = Journal of Clinical Lipidology|doi = 10.1016/j.jacl.2014.09.007|pmid = 25499937|access-date = |volume=8 |pages=554–61}}</ref> Results were presented at the 2014 European Society of Cardiology meeting.<ref>{{Cite web|url = http://www.medscape.com/viewarticle/830729#vp_2|title = Huge Decreases in LDL Cholesterol With Alirocumab: ODYSSEY|date = |accessdate = |website = |publisher = |last = |first = }}</ref>
A phase 3 trial of statin intolerant patients called ODYSSEY ran for 65 weeks.<ref>{{Cite journal|url = |title = 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.|last = |first = |date = Nov–Dec 2014|journal = Journal of Clinical Lipidology|doi = 10.1016/j.jacl.2014.09.007|pmid = 25499937|access-date = |volume=8 |pages=554–61}}</ref> Results were presented at the 2014 European Society of Cardiology meeting.<ref>{{Cite web|url = http://www.medscape.com/viewarticle/830729#vp_2|title = Huge Decreases in LDL Cholesterol With Alirocumab: ODYSSEY|date = |accessdate = |website = |publisher = |last = |first = }}</ref>
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Alirocumab (trade name Praluent) is a human monoclonal antibodyPCSK9 inhibitor biopharmaceutical drug approved by the FDA in July 2015 as a second line treatment of hypercholesterolemia for people whose cholesterol is not controlled by diet and statin treatment. It is also known as REGN727 and SAR236553.
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 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.
Attention: This template ({{cite pmid}}) is deprecated. To cite the publication identified by PMID 24316621, please use {{cite journal}} with |pmid=24316621 instead.
"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. PMID25499937.
