Less than half of the new drug approvals are actually providing therapeutic value to patients, according to a recent study published in The BMJ. Despite the increasing number of drugs being approved in both the U.S. and Europe, it seems that many of them are not significantly improving patient outcomes.
The study focused on 124 first indications that were approved by the FDA and European Medicines Agency (EMA) between 2011 and 2020. Shockingly, only 47% of these first indications in Europe and 41% in the U.S. were rated as having high therapeutic value for patients. It was also observed that a significant portion of these approvals were related to cancer treatments.
Even more concerning were the results for supplemental indications compared to initial indications. Out of the 335 supplemental indications that were approved, only one-third had high therapeutic value for patients. Additionally, when looking specifically at the first three approved indications, second line approvals were found to be 36% less likely and third line approvals were 45% less likely to have a high-value rating compared to first indication approvals.