FDA
12th June 2015

FDA Panel Supports Approval of Repatha

On Wednesday, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 11-4 in favor of approval for Amgen’s Repatha, a cholesterol-lowering drug. 

FDA Panel Supports Approval of Repatha

On Wednesday, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 11-4 in favor of approval for Amgen’s Repatha, a cholesterol-lowering drug. EMDAC also voted 15-0 in favor of having the said drug approved to treat a rare subset of familial hypercholesterolemia, a genetic condition that causes patients to have extremely high levels of cholesterol. Fewer than one million people worldwide are said to suffer from familial hypercholesterolemia. The materials for this meeting can be found HERE

The members of the committee, however, expressed concern around the fact that Amgen had relied on studies that only lasted for a span of 12 weeks.

The panel stressed the face that the goal of LDL-C-lowering therapy is to reduce the risk for cardiovascular (CV) disease. Historically, a change in LDL-C has been considered sufficient to establish the effectiveness of a lipid-altering drug intended for use to reduce cardiovascular risk, without any regulatory requirement to demonstrate evidence for benefit in a CV outcomes trial, provided the reduction is robust and the product (or its class) does not have safety issues that put into question the overall benefit/risk profile.

Amgen has enrolled 27,500 patients in trials that will specifically test the said drug’s ability to impact clinically relevant outcomes, such as lowering the rate of heart attack and other heart diseases compared to the use of statins alone. Amgen expects to be able to present the results of these trials by 2017. In the interim, EMDAC recommended that only those in most need should take the drug until trial results prove that the drug can be used to lower CV disease.

The FDA is not bound by the Advisory Committee’s recommendation but often follows their advice.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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