GEN Exclusives

More »

GEN News Highlights

More »
Jun 26, 2012

FDA Clears Baxter’s Gammagard for Multifocal Motor Neuropathy

  • FDA approved Baxter’s plasma-derived Gammagard Liquid 10% (immune globulin infusion (human)) for improving muscle strength and disability in patients with multifocal motor neuropathy (MMN). Approval is the first in the U.S. for an immunoglobulin therapy for the condition, and follows on from European clearance for the MMN indication, which was granted in 2011.

    The latest FDA approval of Gammagard Liquid was based on placebo-controlled clinical trials demonstrating that the treatment significantly increased mean grip strength, and significantly held back disease-associated deterioration.

    Gammagard (Kiovig outside the U.S. and Canada) is currently approved in 51 countries as a replacement therapy for adult and pediatric patients with primary humoral immunodeficiency including disorders such as common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiences. 


Add a comment

  • You must be signed in to perform this action.
    Click here to Login or Register for free.
    You will be taken back to your selected item after Login/Registration.

Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Climate Change and Disease

Are the incursions of dengue fever and West Nile virus into North America just the tip of the iceberg of insect-borne diseases that are migrating due to a warming planet?