Less Than Half of New Drug Approvals Add Therapeutic Value Over Existing Treatments: Study

A study published in The BMJ on Wednesday reveals that the majority of new drug approvals in the U.S. and Europe do not provide significant therapeutic benefits compared to existing treatments. 

 

The study focused on 124 initial indications approved by the FDA and European Medicines Agency (EMA) between 2011 and 2020. 

It found that less than half of these indications, specifically 47% in Europe and 41% in the U.S., were rated as having high therapeutic value. 

 

The majority of these indications were related to cancer treatments. 

Furthermore, the study highlighted even more disappointing results for supplemental indications when compared to initial indications. 

Only one third of the 335 supplemental indications approved showed significant therapeutic value for patients.

 

Additionally, when examining the first three approved indications, second line approvals were 36% less likely and third line approvals were 45% less likely to receive a high-value rating compared to first indication approvals.

 

Based on these findings, the authors of the study concluded that there is a need for improved information and evaluation of the therapeutic value of new drugs.