Fewer than half of newdrugs add substantial therapeutic value over existing treatments, study finds bmj_latest
finds that less than half of approved first indications for new drugs in the U.S. and Europe between 2011 and 2020 add substantial therapeutic value over existing treatments and only around a third of supplemental approvals add substantial therapeutic value compared with first approvals.
They used publicly available data to identify 124 first and 335 supplemental indications approved by the U.S. Food and Drug Administration and 88 first and 215 supplemental indications approved by the European Medicines Agency between January 2011 and December 2020. Among FDA-approved indications with available ratings, 41% had high therapeutic value ratings for first, compared with 34% for supplemental indications. In Europe, 47% of first and 36% of supplemental indications had high therapeutic value ratings.
As such, they conclude,"Fewer than half of approved first indications in the U.S. and Europe were rated as having high therapeutic value, and the proportion of approved supplemental indications rated as having high therapeutic value was substantially lower than for approved first indications."
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