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news.Baxter International has announced the positive Phase III clinical data of Gammagard Liquid 10% [Immune Globulin Infusion (Human)], used for treating multifocal motor neuropathy (MMN).
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The FDA approved Gammagard Liquid is indicated as replacement therapy for primary humoral immunodeficiency in adult and pediatric patients two years of age or older.
In 44 patients with MMN, the Phase III randomized double-blind placebo-controlled cross-over multi-centre study evaluated whether Gammagard Liquid was superior to placebo in preserving muscle grip strength and preventing progression of disability.
The study showed that Gammagard Liquid demonstrated a 3.75% increase in mean grip strength of affected hand during treatment, as compared to a 31.38% decrease in mean grip strength with placebo administration.
Patients who received placebo experienced progressive disability, as assessed by the Guy’s Neurological Disability Score compared to those receiving Gammagard Liquid.
Baxter BioScience business global research and development vice president Hartmut Ehrlich if approved by the regulatory authorities, Gammagard Liquid will become the first immunoglobulin treatment available for patients with MMN in the US.
In December 2011, the company had filed a supplemental biologics license application with the FDA seeking an indication for Gammagard Liquid to include MMN.