Baxter International's Gammagard liquid 10% [Immune Globulin Infusion (Human)] has got approval from the US Food and Drug Administration (FDA) as a treatment for multifocal motor neuropathy (MMN).
Baxter has been given Orphan Drug Designation in the US as MMN is present between one or two people for approximately 100,000 individuals.
The approval was based on the results of randomised, double-blind, placebo controlled, cross-over study conducted to evaluate the efficacy and safety/tolerability of Gammagard liquid in 44 adult subjects with MMN.
This is the first immunoglobulin approved to treat MMN patients in the US.
The results of the clinical study were submitted during the American Academy of Neurology annual meeting in April 2012.
Baxter BioScience business President Ludwig Hantson said the regulatory approval of Gammagard Liquid for the treatment of MMN is an important milestone for the company as it continues to build its presence in the immunoglobulin market and expand into rare diseases in neurology.
''With GAMMAGARD, we can offer patients with MMN a therapeutic option that has been well studied and used with primary immunodeficiency patients for many years,'' Hantson added.
