$AMGN FDA weighs best patient group


FDA weighs best patient group for Amgen cholesterol drug

FDA seeks expert input on ideal patient group for experimental cholesterol-lowering drug

WASHINGTON (AP) — Federally health regulators say a highly-anticipated, experimental drug from Amgen significantly lowers bad cholesterol. But officials have questions about who should take the drug and whether to approve it based on currently-available data.

The Food and Drug Administration posted its review of Amgen’s Repatha ahead of a Wednesday meeting to consider its approval. Repatha is the part of a new class of injectable, cholesterol-lowing drugs that work differently than older, statin drugs. The new drugs are considered the first major advance in lowering bad cholesterol in more than 20 years.

FDA reviewers say Repatha lowered patients’ cholesterol by 60 percent, on average. But the agency will ask a panel of experts to weigh the drug’s benefits and risks and recommend whether it is better suited for certain patient groups.


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