Advisory Committee Recommend Approval of New Cholesterol Drugs
June 15, 2015 – Last week the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee reviewed two drugs, Praluent (alirocumab), manufactured by Sanofi/Regeneron followed by Repatha (evolocumab), manufactured by Amgen. These drugs are known as proprotein convertase subtilisin/kexin type 9 blockers (PCSK9 inhibitors), which are under FDA review to reduce low-density lipoprotein “bad” cholesterol (LDL-C). During the review which took two days, the committee’s focused on safety (e.g. very low LDL-C levels, neurocognitive effects, and diabetes risk) and the use of LDL-C as a surrogate marker of cardiovascular risk. They also emphasized that statin therapy should be maximized prior to adding a PCSK-9 inhibitor to the therapy.
The advisory committee recommended the approval of both Praluent and Repatha, with votes of 13-3 and 11-4, respectively. The majority of members supported approval for use in patients with heterozygous familial hypercholesterolemia (HeFH), a genetic disorder that causes very high LDL-C levels. In a separate vote, the committee unanimously (15-0) supported approval of Repatha for use in patients with homozygous familial hypercholesterolemia (HoFH), another rare genetic disorder that results in extremely high blood levels of LDL-C.
The committee remained cautious however when it came to using PCSK-9 inhibitors in a broader population of patients with less risk until data from the cardiovascular outcomes trials becomes available in 2017. The FDA considers the recommendations of the advisory committee but does not have to agree with them. The PDUFA date for Praluent is July 24, 2015. Repatha’s Pdufa date is August 27, 2015.
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