In an effort to encourage development of drug treatments for rare diseases, the European Commission, the European Medicines Agency and the U.S. Food and Drug Administration announced steps to streamline the application process for orphan drugs. Companies will be able to simultaneously apply in both jurisdictions using one application.
The U.S. Orphan Drug Act defines a "rare disease or condition" in the case of a drug to mean any disease or condition which a) affects less than 200,000 persons in the U.S; or b) affects more than 200,000 people in the U.S. and for which there is no reasonable expectation that the cost of developing and making available in the U.S. a drug for such disease or condition will be recovered from sales in the U.S. of such drug. In the EU, low prevalence is taken as less than 5 per 10,000 people in the EU. There are estimated to be between 5000 and 8000 such diseases today.
For more information, please see: http://today.reuters.com/news/articlenews.aspx?type=scienceNews&storyID=2007-126T183432Z_01_L2677301_RTRUKOC_0_US-DRUGS-REGULATORS.xml