FDA approves evolocumab as LDL-lowering therapy in certain patients
The FDA has approved evolocumab, a PCSK9 inhibitor, for lowering LDL in adults with heterozygous or homozygous familial hypercholesterolemia or clinical atherosclerotic CVD, according to a press release from the agency.
Evolocumab (Repatha, Amgen) is intended for use in addition to diet and maximally tolerated statin therapy in patients with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic CVD, and in addition to diet and other LDL-lowering therapies for patients with homozygous familial hypercholesterolemia (HoFH), according to an Amgen press release.
The approval follows results from several placebo-controlled trials, including one 52-week study and eight 12-week trials involving patients with primary hyperlipidemia. In phase 3 studies, researchers observed an LDL reduction of 54% to 77% compared with placebo among patients with HeFH or clinical atherosclerotic CVD, and a 30% reduction compared with placebo among patients with HoFH, according to the company release.
“Repatha provides another treatment option in this new class of drugs for patients with familial hypercholesterolemia or with known CVD who have not been able to lower their LDL cholesterol enough with statins,” John Jenkins, MD, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, said in the FDA release.
The most commonly observed adverse events among patients treated with evolocumab in clinical trials included reactions at the injection site, back pain, nasopharyngitis, upper respiratory tract infection and influenza. The effect of the drug on CV-related morbidity and mortality has yet to be determined, according to the company release.
Evolocumab is the second PCSK9 inhibitor to be approved in the United States, after alirocumab (Praluent, Sanofi/Regeneron) received approval in July as an LDL-lowering therapy for patients with HeFH or clinical atherosclerotic CVD. The drug received marketing authorization from the European Commission in July for the treatment of adult patients with primary hypercholesterolemia or mixed dyslipidemia, either alone or in combination with other lipid-lowering therapies, and for patients aged 12 years or older with HoFH, in combination with other lipid-lowering agents.Disclosure: Jenkins is director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research.