FDA Authorizes Device to treat Dialysis-Related Amyloidosis

The FDA has authorized the use of Kaneka’s Lixelle beta 2-microglobulin apheresis column for treatment of dialysis-related amyloidosis, under a humanitarian use device exemption. It is the first device authorized to treat the rare condition.

DRA is caused by the buildup of beta 2-microglobulin protein and occurs most often in patients who have been on hemodialysis for more than five years. As the protein builds up in the blood, it can form deposits in the bones, joints and tendons, causing painful and stiffness. It can also result in bone cysts, which can lead to fractures, torn tendons and ligaments. Deposits can affect the digestive tract, heart and lungs as well, the FDA says.

Lixelle works to remove beta 2 from the blood by passing the blood through the column and then through the dialysis filter.

In a clinical study, about 300 Japanese patients who used the device showed improved in DRA symptoms, the Osaka, Japan, devicemaker said. The HUD exemption requires Kaneka to conduct a U.S. study of Lixelle. — Kellen Owings