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MENAFN Press - 27/11/2012

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Saudi Food and Drug Authority approves New Treatments for Hemophilia
(MENAFN Press) Riyadh, 26th Nov. 2012 “

Saudi Food and Drug Authority (SFDA) has recently approved two drugs used for the treatment and prophylaxis of people with tendency to bleed i.e. hemophilia A and B. This was highlighted in a medical meeting that took place recently in Riyadh and brought together experts in hematology in Saudi Arabia and the UK in conjunction with the 11th Congress of the Saudi Society of Hematology. The new treatments are recombinants DNA-derived factor VIII and factor IX to replace missing clotting factors in hemophilic patients. They are developed through a state-of-the-art manufacturing and purification process that helps reduce the risk of serious viral infections that might be transmitted via infected blood.

"Hemophilia treatments have witnessed exceptional developments following the introduction of plasma-derived options. However, there has been always a need for effective treatments with high safety and efficacy profile that could minimize risk of serious viral infections including HBV, HCV and HIV etc." said Dr. Tarek Owaidah, Consultant Hematologist, Pathology Lab. Medicine, King Faisal Specialist Hospital and Research Centre, "Scientists then developed recombinants derived from human or animal sources. When selecting a plasma-derived or recombinant concentrates, the two most important safety issues are transmission of infectious agents and inhibitor formation1"

Hemophilia is an inherited disease that prevents the blood from clotting properly. People with hemophilia have deficiency blood protein also called clotting factor which is necessary to clot the blood and stop bleeding. Most patients with hemophilia A are dependent on factor VIII replacement therapy, while patients with hemophilia B are dependent on factor IX replacement therapy. According to the World Federation of Hemophilia, 80 per cent of hemophilic patients are afflicted with hemophilia A while 20 per cent of those patients have hemophilia B. Recent studies showed that approximately 320,000 “ 340,000 persons “ predominantly males “ are affected with hemophilia A worldwide. In Saudi Arabia, with a clear absence of accurate statistics of patients with hemophilia however, sporadic studies reveal that the number of those patients may go up to 2000.

There are quite a few elements to be considered in plasma-derived treatments including country of plasma origin, donor selection, viral screening by antibody, direct viral testing and viral screening and inactivation in pooled. Similarly, there are a few considerations for recombinant treatments including eliminating exogenous human or animal proteins and viral removal and inactivation steps reducing.
The newly approved completely albumin-free treatments represent the latest generation of recombinants that employ advancements of manufacturing and purification processes. Using a synthetic ligand that is totally free of animal materials and multiple purification steps including chromatography and nanofiltration, these treatments help to further reduce the risk of potential viral contamination. They are the only recombinant treatments that go through a nanofiltration purification step which is an additional virus removal stage that includes non-enveloped viruses and possible new infectious agents.

Commenting on the complications of hemophilia Dr. Tarek Owaidah, highlighted that few decades ago, children with hemophilia had significantly reduced life expectancy and crippled with arthritis and joint deformity, however with the introduction of new biotechnologically advanced treatment options hemophilic patients faced a few limitations and became more active members in the society closed to normal with increased life expectancy.

"When it comes to treatment, safety is a primary concern for patients. We believe that the state of the art manufacturing and purification process used for the new recombinants make them an effective and safe therapeutic option for many patients with hemophilia." concluded Dr. Owaidah


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