Baxter announced that the FDA has approved Gammagard Liquid 10% (immune globulin infusion [human]) for the treatment of multifocal motor neuropathy (MMN). This is the first immunoglobulin treatment approved for MMN patients in the United States.
The approval was based on the results of a Phase 3, randomized, double-blind, placebo-controlled, cross-over study conducted to evaluate the safety, efficacy, and tolerability of Gammagard Liquid in 44 adults with MMN. The two co-primary endpoints were grip strength in the more affected hand and disability, as measured by Guy’s Neurological Disability Scale. A greater portion of patients who received placebo experienced deterioration compared to those receiving Gammagard Liquid (35.7% vs.11.9%, respectively). The differences in the outcomes of the co-primary endpoints were also statistically significant.
Gammagard Liquid is already indicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients >2 years of age.
For more information call (847) 948-4770 or visit www.baxter.com.