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Repatha review not quite Praluent mirror; dosing stands out

 
• By Donna Young

While it may appear at first glance the FDA's review of Amgen's proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor Repatha (evolocumab) mirrors in many ways what the agency said late last week about Sanofi's and Regeneron Pharmaceuticals' experimental drug in the same class, Praluent (alirocumab), regulators have identified some differences – mostly notably around the dosing of the products.

While it may appear at first glance the FDA's review of Amgen's proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor Repatha (evolocumab) mirrors in many ways what the agency said late last week about Sanofi's and Regeneron Pharmaceuticals' experimental drug in the same class, Praluent (alirocumab), regulators have identified some differences – mostly notably around the dosing of the products.

But it was apparent Dr James Smith, deputy director of the FDA's Division of Metabolism and Endocrinology Products, enjoyed the...

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