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news.Baxter International has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) for approval of Gammagard Liquid 10% [Immune Globulin Infusion (Human)], used to treat multifocal motor neuropathy (MMN).
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Gammagard Liquid is indicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients two years of age or older.
The submission of sBLA is backed by a Phase III, randomized, double-blind, placebo-controlled, cross-over, multi-center study of the efficacy, safety, and tolerability of Gammagard Liquid 10% in a total of 44 MMN patients.
The study assessed whether Gammagard Liquid was superior to placebo administration in the primary and secondary endpoints, including grip strength, and results supported filing for approval in the US.