7:10 PM
Oct 19, 2018
 |  BioCentury  |  Product Development

CVOT damage in diabetes

How FDA’s CVOT guidance has affected diabetes drug development

As FDA reconsiders its requirement for cardiovascular outcomes trials of new diabetes candidates, it’s clear that the development of new therapies has slowed since it was implemented.

In December 2008, FDA issued guidance requiring diabetes companies to show in pre-market studies that new drug candidates do not increase cardiovascular risk by more than 80%, and to conduct post-market cardiovascular outcomes trials to rule out an increase of ≥30%. The agency began implementing that guidance in 1H09.

An analysis by BioCentury of clinical trials for novel drug candidates shows that after reaching a high in 2009, the number of new Phase II and Phase III trials in the U.S. for Type II diabetes drug candidates declined. The...

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