
FDA Panel Recommends Approval of Praluent
An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).
An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-lowering therapy Praluent (alirocumab) on June 9, 2015. Its target action date is July 24, 2015.
Clinical data on Praluent
While patients who do not respond well to statins, have adverse reactions to statins, or patients with a high risk of cardiovascular events could be good candidates for treatment with these mAbs, the advisory panel determined there needs to be more data on cardiovascular clinical trial outcomes to determine that the PCSK9 inhibitors are appropriate for this larger patient population. In briefing documents released ahead of the meeting, the panel wrote, “While cardiovascular events within this application are of interest, the number of adjudicated events is too small overall and within subgroups to make any reliable conclusions regarding the effect of alirocumab on risk of cardiovascular events. The ongoing event-driven cardiovascular OUTCOMES study with an estimated enrollment of 18,000 patients with acute coronary syndrome is designed to establish the effect of alirocumab on cardiovascular morbidity and mortality.” The panel concluded, however, that for patients with heterozygous familial hypercholesterolemia, Praluent’s benefits exceed its risks and the drug fulfills an unmet need.
"The discovery of PCSK9 as a powerful regulator of cholesterol levels and cardiovascular disease was one of the most important human genetic advances of the last decade," said George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president, Regeneron Laboratories, in a
Sanofi and Regeneron essentially
If prescribed to those with severe hypercholesteremia alone,
Amgen announced in late 2014 that it
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