06/08/2015    

HEALTHCARE NEWS

FDA Weighs Approval of First-in-Class Cholesterol Drug

 

Federal health regulators said Friday that a highly anticipated, experimental drug from Sanofi lowers bad cholesterol more than older drugs. But officials have questions about whether to approve the drug based on that measure alone, 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, or LDL, cholesterol since the introduction of blockbuster statin drugs in the late 1980s.

 

In multiple company studies, patients taking Praluent, in addition to a statin, saw their cholesterol fall 46 to 60 percent, depending on the dose taken. That was significantly more than the reduction of 20 to 22 percent for patients taking a statin alone. But FDA regulators are weighing whether to approve Praluent based on its cholesterol-lowering benefit, or whether to wait for longer-term studies designed to show whether it actually reduces heart attacks and death in patients. Those data are still several years away.

 

Source: Associated Press [6/5/15]