목요일, 2월 6, 2025
HomeHealth LawEvolution of orphan drug – Healthcare Economist

Evolution of orphan drug – Healthcare Economist






A research by Fermaglich and Miller (2023) evaluated traits in orphan drug designations and approvals after the Orphan Drug Act of 1983 was handed within the US. The authors use FDA information to guage between 1983 and 2022 and discover that:

Over the 40 years of the ODA, 6,340 orphan drug designations had been granted, representing drug improvement for 1,079 uncommon illnesses. Moreover, 882 of these designations resulted in no less than one FDA approval to be used in 392 uncommon illnesses. A lot of this improvement has been concentrated in oncology as seven of the highest ten most designated and permitted illnesses had been uncommon cancers.

Orphan drug designations and preliminary orphan drug approvals, 1983–2022

Of the orphan drug designations (approvals), the highest 5 high illnesses areas had been:

  • Oncology: 38% of designations (38% of approvals)
  • Neurology: 14% (10%)
  • Infectious Illness: 7% (10%)
  • Metabolism 6% (7%)
  • Hematology: 5% (8%)

You could find extra element on orphan drug designations and approvals within the full paper right here.



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