Orphan drug development: A global perspective

In 1983, the Orphan Drug Act (ODA) was signed into law. Through incentives such as market exclusivity and tax credits, the ODA has encouraged the development of products for the treatment of rare diseases that would not have otherwise been progressed. In the last two decades more than 1300 products have been designated as orphan drugs in the U.S., with 250 receiving market authorization, and affecting thousands of patients worldwide. In this white paper, Fulcrum Pharma Developments Inc. provides an overview of global orphan drug development and describes the similarities and differences in the three major markets: Europe, the U.S. and Japan.

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