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Dkonara921 replied to the topic Drugs banned in US but not in other countries in the forum Regulatory Basics for Medical Devices 7 years ago
Alipogene tiparvovec (Glybera) is a drug synthesized to counter Lipoprotein lipase deficiency (LPLD), a genetic disorder that is known to cause pancreatitis. It was meant to be a means of gene therapy for individuals with LPLD. This drug was approved to be used in Europe in 2012 but it was not approved for use in US. There were plans to make it approved but plans to expand the market to the US were dropped. This drug was known as the “first gene therapy” of the Western Wrold and was the most expensive medicine in the world at the time it was marketed. The cost of the drug made it very uncompetitive in the marketplace. The developer of the drug, Unicure, focused only on selling it to European countries and not the US because there were too few patients.