FDA approves Repatha: FDA Approves Evolocumab

Published: August 29, 2015

FDA approves Repatha: FDA Approves Evolocumab, FDA has approved evolocumab (Repatha-Amgen) injection for certain patients who cannot get their LDL cholesterol under control with other treatment options. Evolocumab, a PCSK9 inhibitor, was cleared for use in addition to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol.

“Repatha provides another treatment option in this new class of drugs for patients with familial hypercholesterolemia or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough with statins,” said John Jenkins, MD, director of the Office of New Drugs, Center for Drug Evaluation and Research. “Cardiovascular disease is a serious threat to the health of Americans, and the FDA is committed to facilitating the development and approval of effective and safe drugs to address this important public health problem.”

Common adverse events associated with the drug include nasopharyngitis, upper respiratory tract infection, flu, back pain, and reactions such as redness, pain, or bruising at the injection site. Allergic reactions have also been reported with the drug.


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