A review of 431 FDA approved drugs from 2010-2020 will be discussed including numbers of drugs within each therapeutic area, increasing use of FDA expedited review categories and a steady approval of first-in-class drugs. In addition, we will discuss how the average time from IND filing to FDA approval was ~8.7 years (± 3.8), which appears to be higher than in past decades. Possible reasons for this will be discussed, including the increasing number of rare and orphan disease indications. Finally, we will discuss what new drugs look like with respect adherence to the “Rule-of-5” (Ro5) for oral small molecule drugs (83% have no violations), but also contrast this to a growing arsenal of new drugs using new modalities such as antisense oligonucleotides (ASO), small-interfering RNA (siRNA) and antibody directed conjugates (ADC).

FDA-approved drugs 2010-2020: Analysis and implications for future drug discovery

ACS Fall 2021

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