The number of orphan drug designations in the US more than doubled in the last decade, growing from 208 during 2000-02 to 425 in 2006-08, says a new study.
Since the US Orphan Drug Act of 1983 was signed into law, more than 2,000 products in development have been designated as orphan drugs, while the Food and Drug Administration (FDA) has granted market approval to 350 drugs and biologics, according to the study, which was conducted by the Tufts Center for the Study of Drug Development (CSDD).
Orphan drugs are products developed for a rare disease or condition affecting fewer than 200,000 people in the US, while in the European Union (EU) they are defined as treatments for diseases or conditions affecting five people out of every 10,000, or fewer.
The National Institutes of Health (NIH) estimates that 25 million Americans have a rare disease.
Filed under: Innovation, Public health Tagged: | access to medicines, drug development, Innovation, orphan drugs, rare diseases
