Studies Highlight Concerns About Accelerated Approval Pathway
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Jan 09, 2025
The FDA’s accelerated approval pathway has become an increasingly popular way for drugmakers to get novel medications to market. However, the strength of clinical evidence from studies supporting these accelerated approvals is not always high. Through the accelerated approval pathway, the FDA allows new drugs to come to market that treat serious conditions, based on pivotal trials that use surrogate endpoints or intermediate clinical endpoints that are “reasonably likely” to predict the clinical benefit. Between 2015 and 2022, 159 drug-indication pairs received accelerated approval. Three pairs were excluded due to absence of the product label or FDA review documents in the Drugs@FDA database. Among the remaining 156 approved drug-indication pairs, 77% were supported with evidence from single-arm pre-approval pivotal studies — trials that had no comparators — and 22% from Phase I trials, according to a recent study published by the BMC Medicine journal. The median number of participants in those trials was 92. Read more
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