Could this be the end of LDL as a surrogate? A possible shift in policy at the FDA means that a much heralded novel new cholesterol drug won’t reach the US market until 2022 at the earliest. Esperion Therapeutics’ bempedoic acid (formerly known as ETC-1002) had previously been thought to be eligible for approval within…
The FDA, Surrogate Endpoints, And Blood Pressure Drugs
April 22, 2013 by Leave a Comment
In recent years the FDA has come under increasing fire for approving drugs on the basis of surrogate endpoints without any evidence of greater clinical benefit. The most famous example of this is the diabetes drug rosiglitazone. Despite strong evidence demonstrating that it was effective at lower blood glucose levels– the surrogate endpoint– serious questions…
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