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12:00 AM
Jun 07, 2010
 |  BioCentury  |  Regulation

Nissen's Exceptional Proposal

Steven Nissen proposes safety shortcut for LDL cholesterol drugs; FDA skeptical

Steven Nissen arguably has done more than anyone else to push FDAto increase its demands for premarket cardiovascular safety data for drugs that will be used on a long-term basis to treat common chronic conditions. Now he wants the agency to lower the safety threshold for compounds that use novel mechanisms of action to lower LDL cholesterol, saying they should be given conditional approval based on a CV safety margin that includes the possibility of increased harm.

The agency hasn't reviewed Nissen's proposal, but it is skeptical about accepting uncertainty about CV harm for therapies that treat dyslipidemia.

While FDA gives itself the latitude to approve compounds that could cause CV events when the risk is outweighed by other benefits, the only reason to lower LDL is to achieve better CV outcomes. Thus, it is unlikely the agency would approve, or physicians would prescribe, an LDL-lowering drug that could cause the heart attacks and strokes that a drug is supposed to prevent.

Nissen, director of cardiovascular medicine at the Cleveland Clinic, was one of the loudest voices calling for withdrawal of COX-2 inhibitors, and he has assailed approval of diabetes drugs like Avandia rosiglitazone from GlaxoSmithKline plc based primarily on blood sugar control.

Now Nissen says he is concerned that the pendulum may have swung too far, driving up the cost and time required to develop LDL-lowering drugs to the point that companies will not pursue alternatives to statins.

"There is some reluctance on the part of FDA to accept biomarker data only for approval of LDL-lowering agents," which has led the agency to require cardiovascular outcomes data prior to approval of agents with new mechanisms of action, Nissen told BioCentury.

"I agree...

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