Baxter submits GAMMAGARD LIQUID sBLA to FDA for treatment of MMN

Baxter International Inc. (NYSE:BAX) today announced that the company has submitted a supplemental biologics license application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] for the treatment of multifocal motor neuropathy (MMN). The product, marketed as KIOVIG outside the United States and Canada, was approved for the MMN indication in Europe in 2011.

"Effective treatment options for MMN are limited and, if approved, GAMMAGARD LIQUID will be the first immunoglobulin treatment approved for MMN patients," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience business. "This filing supports Baxter's commitment to improving patient care, particularly by studying the use of our products in areas where treatment options are limited, such as chronic neurological diseases."

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Baxter International Inc.

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