Octapharma gets FDA approval for new ITP Therapy

According to MarketWatch, the FDA has recently approved a new therapy for ITP patients made by Octapharma. Octagam10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation] has been approved for the treatment of adults with chronic Immune Thrombocytopenic Purpura (ITP) and is indicated in chronic ITP to rapidly raise platelet counts to control or prevent bleeding in adults. It looks like Octagam10% will be available sooner rather than later – Octagam10% is on track to be available in the U.S. in September 2014.

Upon FDA approval, Octapharma USA’s  President, Flemming Nielsen said, “The FDA approval of Octagam10% represents a significant Octapharma milestone, but more importantly, opens up new treatment options for patients. Octagam10% 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.”

According to the prescribing information, Octagam10%  is to be administered intravenously and a total dose of 2 g/kg, divided into two doses of 1 g/kg (10mL/kg) given on two consecutive days. It is contraindicated in people who have a history of anaphylactic or severe systemic reactions to human immunoglobulin and IgA deficient patients with antibodies against IgA and a history of hypersensitivity.

Photo Credit – Octapharma

webleed.org – your source for bleeding news!