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FDA Releases Advisory Committee Report on Amgen's PCSK9 Inhibitor


A preliminary review of Amgen's evolocumab antibody (Repatha) by the Endocrinologic and Metabolic Drugs Advisory Committee, raises a few safety concerns and a call for ongoing monitoring, especially in patients with a high-risk of cardiovascular disease.

While the high price of cholesterol-lowering PCSK9 inhibitors, being developed by Amgen and Regeneron/Sanofi, has been in the news for some time now, FDA made progress in decisions on the clinical front. Yesterday, FDA released a report of its Endocrinologic and Metabolic Drugs Advisory Committee on Amgen's PCSK9 inhibitor evolocumab (Repatha).

Some of the topics of discussion by the committee included:

1. Overall drug safety based on the clinical development program.

2. Optimal and safe dose for using the antibody as a cholesterol-lowering agent and to treat homozygous familial hypercholesterolemia.

3. Whether the drugs cholesterol-lowering effect is sufficient to reduce a person's cardiovascular risk.

The committee raised safety issues, specifically asking for long-term studies and the need to assess risk in patients with a high cardiovascular disease burden who are on the highest dose of statins. Additionally, if approved, the committee called for addressing some observed safety concerns like pancreatitis and renal disorders with appropriate labeling.

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