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FDA Approves Octagam® 10% for Chronic ITP

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FDA Approves Octagam® 10% for Chronic ITP

July 23, 2014
FDA Approves Octagam® 10% for Chronic ITP

On July 17, the US Food and Drug Administration (FDA) approved a new treatment for adults with chronic immune thrombocytopenic purpura (ITP). Developed by Octapharma USA, Octagam® 10% is administered intravenously. The therapy is manufactured from highly purified immunoglobulin derived from large pools of human plasma.

ITP, also called idiopathic thrombocytopenic purpura, is a bleeding disorder in which the immune system destroys platelets, which are necessary for clotting. Symptoms include the appearance of petechiae (clusters of red spots where capillaries below the skin have bled), excessive bruising, nose bleeds and bleeding of the gums associated with dental procedures. In addition, women with ITP may experience heavier and/or prolonged menstrual bleeding.

The approval of Octagam 10% is based on the results of an Octapharma-sponsored clinical trial that evaluated the safety and efficacy of the product in 66 patients with chronic ITP between the ages of 17-88. Of those, 81.8% attained the primary efficacy endpoint of clinical response within 7 days of dosing, which was significantly higher than the predicted responder rate of 70%. Investigators also reported no unexpected tolerability issues, even at the “maximum infusion rate.”  Further, 78% of patients with chronic ITP, who had bleeding at the beginning of the trial, reported no bleeding 7 days after treatment. Side effects included headache, fever and elevated heart rate.

Octagam 10% is not indicated in people with a history of anaphylaxis. Further, a warning label will mention the increased risk of thrombosis.

“FDA approval of Octagam 10% represents a significant Octapharma milestone, but, more importantly, opens up new treatment options for patients,” said Octapharma USA President Flemming Nielsen. “Octagam 10% has demonstrated safety and efficacy in a pivotal clinical trial. Octapharma looks forward to providing the product in the U.S., further advancing our vision of providing patients with therapies to treat life-threatening conditions.” Octagam 10% is anticipated to be available in the US by September 2014.

Source: MarketWatch, July 15, 2014