FDA Panel Reviews Long-Term Safety of Experimental Treatment for Immune System Disorders
According to Reuters, the U.S. Food and Drug Administration (FDA) met on July 31, 2014 to review and discuss both the risks and benefits of Baxter International, Inc.’s experimental treatment for different hereditary immune system disorders.
The product, HyQvia, is designed to treat primary immunodeficiency disorders that could lead to infections, recurrent pneumonia, and abscesses of the organs due to the fact that the immune system is missing certain cells.
In 2012, the FDA declined to approve HyQvia after Baxter’s data showed that while the drug elevated antibodies, which fight foreign bodies, it had no clinical impact on patients. The agency was also concerned that potential long-term exposure to the drug could cause inflammation of the brain and bowel, as well as infertility problems. The FDA highlighted that as it stands now the product provides a mere convenience and not a clear benefit.
Dr. Eun Yang, an analyst at Jefferies LLC, said that given concerns specifically over male fertility, the commercialization of the drug would be “very limited.” Dr. Yang estimated that U.S. and European total sales may only reach $740 million overall. HyQvia was approved in Europe in 2013.
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