Send to printer »

GEN News Highlights : Jun 26, 2012

FDA Clears Baxter’s Gammagard for Multifocal Motor Neuropathy

Firm says drug is the first immunoglobulin therapy approved in U.S. for MMN.

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.