Genetic Evidence Supports Many FDA Drug Approvals: Study

Wellcome Genome researchers in the UK say that for 33 of the 50 (66%) FDA-approved new drugs in 2021, the genes coding for their primary assigned targets, or for proteins that are known to physically interact with the targets, have been previously associated in some way with the indication for which the drug is approved or a closely related phenotype. Writing in the journal Nature, the researchers cite examples from the approvals demonstrating the value of the underlying genetic evidence.

“While genetics might not have influenced the decision-making behind some of the genetically supported approved drugs,” the article concludes, “the availability of such evidence can retrospectively help to understand the causal mechanisms behind their therapeutic efficacy or safety. In the future, positive outcomes for genetically supported therapeutic strategies will need to be assessed rigorously to avoid the risk of confirmation bias.”