sBLA Submitted for Gammagard Liquid for Multifocal Motor Neuropathy
Baxter International announced that it has submitted a supplemental Biologics License Application (sBLA) for Gammagard Liquid 10% [immune globulin infusion (human)] for the treatment of multifocal motor neuropathy (MMN).
The submission is based on a Phase 3, randomized, double-blind, placebo-controlled, cross-over, multicenter study of the efficacy, safety, and tolerability of Gammagard Liquid in a total of 44 MMN patients. The study evaluated whether Gammagard Liquid was superior to placebo administration and results supported filing for approval.
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.