Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study

BMJ

5 July 2023 - The objective was to analyse the therapeutic value of supplemental indications compared with first indications for drugs approved in the US and Europe.

The cohort study included 124 first and 335 supplemental indications approved by the FDA and 88 first and 215 supplemental indications approved by the EMA between 2011 and 2020; the largest subset was for cancer disorders.

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Michael Wonder

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Michael Wonder

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Medicine , Europe , Regulation