Healthcare company Baxter International, Inc. (BAX) said Monday it received approval from the U.S. Food and Drug Administration or the FDA for GAMMAGARD LIQUID 10% as a treatment for multifocal motor neuropathy or MMN.
The approval was based on the results of a randomized, double blind, placebo controlled, crossover study conducted in 44 adult subjects with MMN. The most common adverse reactions during infusion with the LIQUID were headache, chest discomfort, muscle spasms, muscular weakness, nausea, oropharyngeal pain, and pain in extremity. The serious adverse reactions were pulmonary embolism and blurred vision, which were judged to be treatment-related.
GAMMAGARD LIQUID 10% is the first immunoglobulin treatment approved for MMN patients in the United States, and it was approved for use with MMN patients in Europe in 2011. GAMMAGARD LIQUID, also known as KIOVIG outside the United States and Canada, was originally approved by the US FDA in September 2005.
MMN is associated with a progressive, asymmetric limb weakness mostly affecting the upper limbs, which can lead to significant difficulty with simple manual tasks. Almost 80 percent of people with MMN are between 20 and 50 years of age at onset of the disease, and men are more frequently affected than women. Baxter has been granted Orphan Drug Designation for this indication in the United States, as the prevalence of MMN is estimated at between one or two people for approximately 100,000 individuals.
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