Press Release

FDA grants HUD (Humanitarian Use Device) Designation to Gambro’s Theralite™

Feb 10, 2010 16:01 GMT

This is the first step toward obtaining marketing approval in the U.S. The Theralite High Cut-off technology has been commercially available since 2007 in Europe and was recently granted regulatory approval in Canada.

Multiple Myeloma patients with acute kidney failure have traditionally had limited treatment options available to effectively reduce the concentration of Free Light Chains (FLCs) in the blood to allow the kidney to recover function. 2,3 With the introduction of the Theralite High Cut-off Technology, it is possible to achieve a rapid reduction of FLCs in combination with effective dialysis treatment. In pilot studies, the kidney function was restored in as many as 70% of the patients participating in the studies. 1

"The experience from physicians that have treated more than 1400 multiple myeloma patients indicates that renal failure lasting longer than 3 months is almost universally irreversible and quadruples mortality. A treatment removing nephrotoxic Free Light Chains has a great potential for markedly improving both the survival and the quality of life of patients with multiple myeloma." says Dr. Carl M. Kjellstrand, MD, PhD, a US nephrologist.

“The HUD designation by the FDA is the first step toward bringing this novel therapy to patients affected with this condition in the U.S.  In Europe and elsewhere the therapy has shown great potential in preventing the need for ongoing dialysis treatment and improving quality of patient lives,” says Chuck Immel, President Gambro Ventures.

About Multiple Myeloma:
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a progressive hematologic (blood) disease. It is a cancer of the plasma cells. The plasma cells are an important part of the immune system that produce immunoglobulins (antibodies) which help to fight infections and diseases. Multiple myeloma is characterized by excessive numbers of abnormal plasma cells in the bone marrow and overproduction of intact immunoglobulins (IgG, IgA, IgD, or IgE) or free light chains. Hypocalcaemia, anemia, renal damage, increased susceptibility to bacterial infection, and impaired production of normal immunoglobulins are common clinical manifestations of multiple myeloma. Immunoglobulins are made up of protein chains, two long chains called heavy chains and two shorter chains known as light chains. Although a high level of myeloma related immunoglobulins in the blood is a sign of myeloma disease, about 15% to 20% of patients with myeloma also produce incomplete immunoglobulins which contain only the light chain portion of the immunoglobulin. These free light chains may deposit in the kidney and clog the tiny tubules that make up the kidney's filtering system, which can eventually cause kidney damage and resulting in kidney failure. Source: http://www.themmrf.org

References:

  1. Hutchison CA, et al. Treatment of acute renal failure secondary to multiple myeloma with chemotherapy and extended high cut-off hemodialysis. Clin J Am Soc Nephrol 2009;4:745–754
  2. Leung N, et al. Improvement of cast nephropathy with plasma exchange depends on the diagnosis and on reduction of serum free light chains. Kidney Int 2008;73:1282–1288.
  3. Cserti C, et al. Light-chain removal by plasmapheresis in myeloma-associated renal failure. Transfusion 2007;47:511–514.

For further information please contact:
Anne Bonelli, Director Marketing Communications, +1 303-231-4671
Maria Lundbäck, Director External Communications, +46 705 136534

 

* Humanitarian Device. Humanitarian Use Device designation granted by FDA for use to remove serum free light chains (FLC) which can lead to cast acute renal failure in patients with multiple myeloma. The effectiveness of this device for this use has not been demonstrated.