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Current Status of EPD

            The manufacturer of EPD (McEwen Laboratories, LTD, England) tried to submit an IND (investigational new drug) application to the FDA in an attempt to obtain FDA approval many years ago. The process was overwhelming and far too costly, and failed.  (Note: The American EPD Study was conducted before the manufacturer began the IND submission process.)  The FDA banned EPD immunotherapy in the United States in April of 2002, pending approval of the drug, and placed EPD on their Import Alert List.  Until early in 2004, the FDA was allowing some personal importation of EPD by patients, but importation has now been severely restricted and EPD is no longer available under any circumstance in the USA.  EPD is used in Canada, Europe and several other countries outside the E.U.

            McEwen recently (2012) sold his interest in EPD manufacture, and as we understand it, EPD is now manufactured and distributed, for use in countries that allow it, by physicians who have formed a company in San Morino (a small independent country in Italy).

            It is very highly unlikely that EPD or LDA will ever receive FDA approval.  The costs of FDA approval (the average cost of the average drug approved today is over 800 million dollars and now closer to a billion) are simply too great to allow either to be a financially viable treatment, even if they were approved.  Further, the number of allergens contained in EPD and LDA is far too great for the FDA to consider approval, since the FDA's approval slogan is effectively, "one drug, one indication".

   

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Copyright 2005 Santa Fe Center for Allergy and Environmental Medicine
Last modified: April 20, 2015