3/28/19 - Kaneka Pharma America LLC in the News

Kaneka Pharma America is pleased to announce that the FDA approved the modification of the indications for the use (IFU) of Kaneka’s LIPOSORBER® LA-15 system. This approval will allow more US patients to use our apheresis treatment to lower low-density lipoprotein cholesterol (LDL-C) levels. The FDA made the following modification:
The LDL-C cut-off in Group C is now reduced to 100 mg/dL from 160 mg/dL.

The LIPOSORBER IFU as of March 28, 2019:
The LIPOSORBER LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma of the following high-risk patient populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated:

  • Group A – Functional Hypercholesterolemic Homozygotes with LDL-C >500 mg/dL;
  • Group B – Functional Hypercholesterolemic Heterozygotes with LDL-C ≥300 mg/dL; and
  • Group C – Functional Hypercholesterolemic Heterozygotes with LDL-C ≥100 mg/dL and either documented coronary artery disease or documented peripheral artery disease.

In accordance with FDA requirements, Kaneka will revise our labeling to reflect the approved new indications for use. While we make those updates, this new indication is effective as of March 28, 2019. Attached is the FDA’s approval letter for more information. Kaneka believes this development will assist physicians in their treatment plans for patients with severe hypercholesterolemia. If you have any questions, please contact us at 612-590-9446.

Naoto Oyama
President, Kaneka Pharma America LLC

Read the FDA Letter

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To contribute to human well-being through the application of biomedical engineering in the research, design, and sale of devices that promote health.

Kaneka Pharma America is committed to:

  • Providing safe, high-quality, and user-friendly products
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