2021 in review: FDA approvals of new medicines

The year 2021 witnessed a remarkable number of US Food and Drug Administration (FDA) approvals and registered clinical trials. In total, 60 new molecular entities (NMEs) were approved by the FDA, the highest level achieved in the post-Prescription Drug User Fee (PDUFA) era and tied with 2018. Of these NMEs, 49 used the incentives of the Orphan Drug Act or were approved under Priority, Fast-Track, Accelerated, and/or Breakthrough designations. Looking further, the number of registered clinical trials was off its 2020 record peak but well within the 5-year running average. Nonetheless, these remarkable outcomes were tempered by the fact that the rate of industry consolidation and turnover continued apace, reducing the number of organizations involved in the clinical development of new medicines and raising questions about long-term sustainability.

Automated summary

In 2021, the FDA approved 60 new molecular entities (NMEs), reaching the highest level in the post-PDUFA era. Among these NMEs, 49 utilized the incentives of the Orphan Drug Act or obtained approval under Priority, Fast-Track, Accelerated, and/or Breakthrough designations. Although the number of registered clinical trials was lower than the 2020 peak, it remained within the 5-year running average. The rate of industry consolidation and turnover, however, raised concerns about the long-term sustainability of organizations involved in clinical development.