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Evinacumab
Monoclonal antibody From Wikipedia, the free encyclopedia
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Evinacumab, sold under the brand name Evkeeza, is a monoclonal antibody medication for the treatment of homozygous familial hypercholesterolemia (HoFH).[4][5][6]
Common side effects include nasopharyngitis (cold), influenza-like illness, dizziness, rhinorrhea (runny nose), and nausea. Serious hypersensitivity (allergic) reactions have occurred in the Evkeeza clinical trials.[5]
Evinacumab binds to the angiopoietin-like protein 3 (ANGPTL3).[5] ANGPTL3 slows the function of certain enzymes that break down fats in the body.[5] Evinacumab blocks ANGPTL3, allowing faster break down of fats that lead to high cholesterol.[5] Evinacumab was approved for medical use in the United States in February 2021.[5][9][10] The U.S. Food and Drug Administration considers it to be a first-in-class medication.[11]
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History
Regeneron invented evinacumab.[12]
The effectiveness and safety of evinacumab were evaluated in a double-blind, randomized, placebo-controlled, 24-week trial enrolling 65 participants with homozygous familial hypercholesterolemia (HoFH).[5] In the trial, 43 participants received 15 mg/kg of evinacumab every four weeks and 22 participants received the placebo.[5] Participants were taking other lipid-lowering therapies as well.[5] The trial was conducted in the United States, Italy, France, Greece, Netherlands, Austria, Canada, Australia, New Zealand, Ukraine, South Africa, and Japan.[6]
The primary measure of effectiveness was the percent change in low-density lipoprotein (LDL-C) from the beginning of treatment to week 24.[5] At week 24, participants receiving evinacumab had an average 47% decrease in LDL-C while participants on the placebo had an average 2% increase.[5]
The U.S. Food and Drug Administration (FDA) granted the application for evinacumab orphan drug, breakthrough therapy, and priority review designations.[5][11] The FDA granted approval of Evkeeza to Regeneron Pharmaceuticals, Inc.[5]
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Society and culture
Legal status
In April 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization under exceptional circumstances for the medicinal product Evkeeza, intended for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).[7] The applicant for this medicinal product is Regeneron Ireland Designated Activity Company (DAC).[7] Evinacumab was approved for medical use in the European Union in June 2021.[7]
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References
Further reading
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