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In July 2015, the FDA approved alirocumab as a second line treatment 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/>
In July 2015, the FDA approved alirocumab as a second line treatment 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/>
==Research==
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 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>
== References ==
== References ==
Revision as of 20:16, 25 July 2015
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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 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.
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^ Alirocumab label Label revised, July 2015. Page accessed July 25, 2015
