FDA acts to approve a new cholesterol lowering medicine called evolocumab (Repatha)

king The FDA approved evolocumab (Repatha)

August 27, 2015

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kingThe FDA approved evolocumab (Repatha)

August 27, 2015

The FDA approved a new cholesterol lowering medicine called Repatha for people who are not able to get their low-density lipoprotein (LDL) under control with diet and currently available medicines in the statin (HMGCoA reductase inhibitors) family. This follows the European Medicines Agency (EMA) approval of Repatha as the first-in-class PCSK9 inhibitor treatment May 22, 2015. The FDA previously approved a PCSK9 inhibitor called alirocumab (Praluent) for heterozygous familial hypercholesterolemia.

Repatha belongs to this new family (class) of medicines known as PCSK9 inhibitors. The medicine is actually a monoclonal antibody that inhibits PCSK9 and that inhibition leads to lower cholesterol. It is approved “for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options.”

Repatha is approved (indicated for):

1)      Use in addition to diet and maximally-tolerated therapy with statin type (such as Lipitor-atorvastatin or Crestor-rosuvastatin) therapy in adults with heterozygous familial hypercholesterolemia  (HeFH) or

2)      Use in homozygous familial hypercholesterolemia (HoFH) or

3)      Use in clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

More information on the uses and terms in this release is available at:

Statin therapy: http://nlm.nih.gov/medlineplus/statins.html

Hypercholesterolemia: http://ghr.nlm.nih.gov/condition/hypercholesterolemia

Atherosclerotic cardiovascular disease: http://www.nhlbi.nih.gov/health/health-topics/topics/atherosclerosis/

A long-term study called FOURIER is currently underway. Fourier stands for Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk. The purpose of this study is to see if evolocumab (Repatha) is well-tolerated and decreases the risk of cardiovascular death, heart attack (myocardial infarction), hospitalization for unstable angina, stroke or coronary revascularization in people (subjects) with clinically evident cardiovascular disease. Visit www.clinicaltrials.gov and search NCT01764633 for more information.

Every medicine has a profile of benefits and risks as you've seen in the Essential Guide To Prescription Drugs. Most common side effects of Repatha include inflammation of the nasopharynx (nasopharyngitis), upper respiratory tract infection, flu, back pain, and reactions such as redness, pain, or bruising where the shot (injection) is given. There have been allergic reactions reported (such as rash and hives). People should stop taking Repatha and get medical help if they start to have these symptoms. The FDA press release is at www.FDA.gov.

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This website is not intended as medical advice, and you should consult your doctor before changing or adding any medicines or vitamins to those you may now be taking and about applying any strategies BEFORE you adopt any approach in this report. While diligent care has been taken to ensure the accuracy of the information provided during the preparation of this edition, no claim is made that all known actions, uses or side effects, strategies for cost containment, targets or cholesterol pathways are included in this report. The accuracy and currentness of information are ever subject to change relative to new guidelines, new information derived from drug research, development and general usage.