FDA Approves Subcutaneous Gammagard - Drug Discovery and Development

Baxter International Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous administration of GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] for patients with primary immunodeficiency (PI). The approval of this new route of administration will allow physicians and PI patients to work together to determine which route of administration of GAMMAGARD LIQUID is most appropriate. Subcutaneous use of GAMMAGARD LIQUID allows patients to self-administer their therapy at home on a weekly basis.

“The FDA approval of a subcutaneous route of administration for GAMMAGARD LIQUID offers PI patients the option to administer GAMMAGARD LIQUID either intravenously or subcutaneously, depending on their individual needs,” said Richard Schiff, M.D., Ph.D., medical director for Baxter’s gammaglobulin trials. “Building upon years of strong clinical data of GAMMAGARD LIQUID, our subcutaneous clinical trial in patients with PI demonstrated efficacy consistent with that seen in other clinical studies of intravenous and subcutaneous immune globulin.” (The most frequently reported adverse reactions were local site reactions, which occurred in 2.7% of infusions.)

Baxter supports advocacy organizations and treatment centers through programs focusing on patient care and continued access to therapy such as GARDian, a program providing educational resources, insurance support and guidance for therapy continuity. The GARDian program is also creating new features to support patients who choose GAMMAGARD LIQUID for subcutaneous use.

GAMMAGARD LIQUID is indicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients two years of age or older. It offers flexibility to clinicians who treat patients with PI, as it is now available via two routes of administration, in a total of five dosing sizes, and contains no added sugars, sodium, or preservatives. It is processed using a dedicated three-step viral inactivation/removal process.

Date: July 25, 2011
Source: Baxter International Inc.