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'''Alirocumab''' (trade name '''Praluent''') is an experimental human ] ] inhibitor designed for the treatment of ].<ref>, World Health Organization</ref> It is also known as '''REGN727''' and '''SAR236553'''.<ref name=sheridan2013>{{cite pmid|24316621}}</ref> It was discovered by ] and is being co-developed with ]. A main competitor in the race to worldwide health authority approval is ] in development by Amgen. |
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'''Alirocumab''' (trade name '''Praluent''')<ref>, World Health Organization</ref> is a human ] ] inhibitor ] drug approved by the FDA in July 2015 as a second line treatment of ] for people whose cholesterol is not controlled by diet and ] treatment. It is also known as '''REGN727''' and '''SAR236553'''.<ref name=sheridan2013>{{cite pmid|24316621}}</ref> It was discovered by ] and is being co-developed with ]. A main competitor in the race to worldwide health authority approval is ] in development by Amgen. |
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==History== |
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In July of 2015, it was approved by the FDA for the lowering of LDL ("bad") cholesterol in those where the levels are too high, including those who suffer from disorders, most of them genetic, that result in abnormally elevated LDL cholesterol levels, a broad group of people, and arguably the most significant anti-LDL cholesterol drug to hit the U.S. market since ] introduction, in 1987. However, its cost can be prohibitive, at around $15,000 US per year, even for patients with insurance and prescription assistance.<ref>http://www.msn.com/en-us/news/us/fda-approves-new-cholesterol-drug-at-dollar14600-a-year/ar-AAdsOdi</ref> |
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In July 2015, the FDA approved alirocumab to lower ] for people who have ] and people with ] who require additional lowering of LDL cholesterol when diet and ] treatment have not worked.<ref name=FDA2014>FDA. July 24, 2015 </ref> This was the first approval of a ] inhibitor.<ref name=FDA2014/> |
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==Research== |
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== Clinical trials == |
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== Clinical trials == |
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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> |
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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> |
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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.<ref>{{Cite journal|title = Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events|url = http://dx.doi.org/10.1056/NEJMoa1501031|journal = New England Journal of Medicine|date = April 16, 2015|issn = 0028-4793|pmid = 25773378|pages = 1489-1499|volume = 372|issue = 16|doi = 10.1056/NEJMoa1501031|first = Jennifer G.|last = Robinson|first2 = Michel|last2 = Farnier|first3 = Michel|last3 = Krempf|first4 = Jean|last4 = Bergeron|first5 = Gérald|last5 = Luc|first6 = Maurizio|last6 = Averna|first7 = Erik S.|last7 = Stroes|first8 = Gisle|last8 = Langslet|first9 = Frederick J.|last9 = Raal}}</ref> |
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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.<ref>{{Cite journal|title = Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events|url = http://dx.doi.org/10.1056/NEJMoa1501031|journal = New England Journal of Medicine|date = April 16, 2015|issn = 0028-4793|pmid = 25773378|pages = 1489-1499|volume = 372|issue = 16|doi = 10.1056/NEJMoa1501031|first = Jennifer G.|last = Robinson|first2 = Michel|last2 = Farnier|first3 = Michel|last3 = Krempf|first4 = Jean|last4 = Bergeron|first5 = Gérald|last5 = Luc|first6 = Maurizio|last6 = Averna|first7 = Erik S.|last7 = Stroes|first8 = Gisle|last8 = Langslet|first9 = Frederick J.|last9 = Raal}}</ref> |
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==History== |
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In July 2015, the FDA approved alirocumab to lower ] for people who have ] and people with ] who require additional lowering of LDL cholesterol when diet and ] treatment have not worked.<ref name=FDA2014>FDA. July 24, 2015 </ref> This was the first approval of a ] inhibitor.<ref name=FDA2014/> |
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== References == |
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== References == |
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.
