Repurposing existing drugs for new uses: a cohort study of the frequency of FDA-granted new indication exclusivities since 1997.

ABSTRACT:

Background

Drug repurposing (i.e., finding novel uses for existing drugs) is essential for maximizing medicines' therapeutic utility, but obtaining regulatory approval for new indications is costly. Policymakers have therefore created temporary indication-specific market exclusivities to incentivize drug innovators to run new clinical investigations. The effectiveness of these exclusivities is poorly understood.

Objective

To determine whether generic entry impacts the probability of new indication additions.

Methods

For a cohort of all new small-molecule drugs approved by the FDA between July 1997 and May 2020, we tracked new indications added for the subset of drugs that experienced generic entry during the observation period and then analyzed how the probability of

SUBMITTER: Sahragardjoonegani B 

PROVIDER: S-EPMC7780607 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature