In The News

FDA Gives Premarket Approval for Modification of LDL Indications for Use of Lipoprotein Apheresis System

by Seth J. Baum, MD, FACC, FACPM, FAHA, FNLA

The FDA has granted premarket approval to Kaneka Pharma America’s application requesting approval for modification of the indications for use of their Liposorber LA-15 System. The major gain for patients is that LDL can now be 160 or greater whereas previously it had to be 200 or greater, making it easier now to treat high risk patients.

Lipoprotein apheresis (LA), formerly known as LDL apheresis, is a safe,
effective, and very well-tolerated procedure performed in approximately
sixty centers in the US. The procedure is used around the world for
patients with a genetic disorder called familial hypercholesterolemia
(FH). Such individuals experience very high cholesterol levels and are
therefore at great risk for premature heart attacks, strokes, and even

LA has been approved in the US since the 1990s yet many insurance
providers continue to make patient access to the procedure quite
cumbersome. Consequently only 450 or so patients in the US are currently
undergoing LA, though well over 1 million FH patients live in the US. Many
clinical lipidologists across America (including me) have spent countless
hours attempting to inform the “powers that be” about the great utility of
LA. Oftentimes, but not always, our efforts have failed. Now we have an
example of an apparent success. In my LA clinic – although anecdotal –
patients have experienced dramatic improvements in symptoms and reductions
in cardiovascular events. I, like all of my LA colleagues in the US and
across the globe, am convinced about this technique’s utility. I applaud
our FDA for their bold move.

I thank the FDA on behalf of my patients and
on behalf of those patients who hopefully will soon be able to avail
themselves of this potentially lifesaving technology.