Talecris Biotherapeutics (Nasdaq: TLCR) announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex®-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).
The newly approved Gamunex-C provides both the intravenous route of administration and a new subcutaneous route of administration. The intravenous delivery mode is approved to treat PI, chronic inflammatory demyelinating polyneuropathy (CIDP), and idiopathic thrombocytopenic purpura (ITP). The subcutaneous mode is approved to treat only PI.
The difference between Gamunex and Gamunex-C is the labeling and packaging information. Gamunex-C labeling describes both the intravenous and subcutaneous routes of administration, whereas Gamunex labeling describes only intravenous administration. Subcutaneous administration delivers the product under the skin into the subcutaneous tissue and intravenous administration is delivered through a vein.
"The FDA approval of Gamunex-C is important because it provides another option for patients with primary immunodeficiency and their healthcare professionals when they are considering the various treatment modalities," said Fred Modell, Co-Founder of the Jeffrey Modell Foundation. "We consider it significant for patients to have multiple modes of delivery so they can select the option that best suits their individual needs."
Through its FDA approval, Gamunex-C becomes the first and only immunoglobulin therapy approved in the U.S. with both intravenous and subcutaneous routes of administration to treat PI. In clinical studies of Gamunex-C, the most common adverse reactions associated with subcutaneous administration were infusion site reactions, headache, fatigue, arthralgia and pyrexia.
"The approval of Gamunex-C is an exciting milestone in the treatment of primary immunodeficiency diseases, giving patients another choice to help manage their health," said Marcia Boyle, President and Founder, Immune Deficiency Foundation. "The Immune Deficiency Foundation applauds Talecris Biotherapeutics for its commitment to providing therapies for our community."
SOURCE Talecris Biotherapeutics, Inc.