Medicine Approvals for Rare Dise

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					    Medicine Approvals for Rare Diseases

                 Drug Approvals for Rare Diseases Have Increased from
                           Fewer than 10 to More than 160
                                                                                                    Rare diseases are those that
                                                                                                    affect 200,000 or fewer people in
                 160                                                                                the U.S. In total, 25 million
                                                                        160                         Americans have rare diseases.
Drug Approvals




                 120

                                               108                                                  The Orphan Drug Act (ODA) was
                                                                                                    passed in 1983 to encourage the
                  80                                                                                research and development of
                                                                                                    medicines to treat rare diseases.
                                                                                                    Since then, the FDA has approved
                  40                                                                                more than 200 medicines for rare
                                                                                                    diseases.
                           10
                   0
                          1970's           1984–1994                1995–2005


Note: All medicines approved for rare diseases include first-line approvals and subsequent approvals for new disease areas
Sources: FDA, Office of Orphan Product Development, List of All Approved Orphan Products Through the Year 2005 and
Orphan Products Development, at http://www.fda.gov/orphan; NIH, Office of Rare Diseases, “Biennial and Annual Report
on the Rare Diseases Research Activities at the National Institutes of Health, FY 2004,” 2005.

				
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posted:9/18/2010
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