FDA approves Repatha injection
Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, has been approved by the FDA for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol.
Familial hypercholesterolemia (encompassing both HeFH and HoFH) is an inherited condition that causes high levels of LDL cholesterol. A high level of LDL cholesterol in the blood is linked to cardiovascular or heart disease. Heart disease is a leading cause of death for Americans, both men and women. According to the Centers for Disease Control and Prevention, about 610,000 people die of heart disease in the U.S. every year—that figure equals one in every four deaths.
The efficacy and safety of Repatha were evaluated in one 52-week placebo-controlled trial and eight 12-week placebo-controlled trials in participants with primary hyperlipidemia, including two that specifically enrolled participants with HeFH and one that enrolled participants with HoFH. In one of the 12-week studies, 329 participants with HeFH who required additional lowering of LDL cholesterol despite statins with or without other lipid-lowering therapies were randomized to receive Repatha or placebo for 12 weeks. Participants taking Repatha had an average reduction in LDL cholesterol of approximately 60%, compared to placebo.
The most common side effects of Repatha include nasopharyngitis, upper respiratory tract infection, flu, back pain and reactions such as redness, pain or bruising where the injection is given. Allergic reactions such as rash and hives have been reported with the use of Repatha.
Repatha is marketed by Amgen of Thousand Oaks, Calif.