WASHINGTON (AP) — Federal health regulators say a highly-anticipated, experimental drug from Sanofi significantly reduces bad cholesterol. But they have questions about whether that benefit warrants approval now or whether to wait for additional study results.
The Food and Drug Administration posted its review of Sanofi’s Praluent ahead of a meeting next week to consider the drug’s approval. Praluent is the first in a new class of cholesterol-lowering biotech drugs to come before the FDA. The drugs are considered the first major advance in lowering bad cholesterol since the introduction of blockbuster statin drugs in the late 1980s.
But FDA regulators are weighing whether to approve Praluent based on its cholesterol-lowering power alone, or whether to wait for longer-term studies designed to show whether it actually reduces heart attacks and death in patients.