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FDA authorizes Lixelle column for dialysis-related amyloidosis

FDA authorized use of the first device for the treatment of dialysis-related amyloidosis today, Lixelle Beta 2-microglobulin Apheresis Column.

“While [dialysis-related amyloidosis] affects only a small population of patients on dialysis, there are not many treatment options for these patients and some options may not be available to patients in all areas. The Lixelle Beta 2-microglobulin Apheresis Column may provide this patient population with an option for relieving some of the debilitating symptoms of DRA,” William Maisel, MD, MPH, deputy director for science, chief scientist and acting director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health, said in a press release.

William Maisel

The Lixelle Column (Kaneka Pharma America), used in conjunction with hemodialysis, works by removing the protein beta 2-microglobulin from the blood, according to the release. The patients’ blood passes through the Lixelle Column, which contains porous cellulose beads intended to bind to beta 2-microglobulin, before entering the dialysis filter.

The company behind the Lixelle Column, Kaneka Corporation in Osaka, Japan, provided data on use of the device for the treatment of 100 patients with dialysis-related amyloidosis, and postmarket safety data for 200 patients in Japan. Both studies showed improvement in dialysis-related amyloidosis symptoms with Lixelle Column use. Temporary hypotension and a decrease in red blood cell count are the most common adverse events associated with the Lixelle column.

After FDA reviewed the Lixelle Column through the Humanitarian Device Exemption (HDE) pathway, it was granted a Humanitarian Use Designation, according to the release. The Kaneka Corporation must conduct a postmarket study to assess the benefits, risks and adverse events of Lixelle among the U.S. population as a condition of the HDE approval.