FDA Publishes List of Surrogate Endpoints Used in Drug Approvals

The list includes surrogate endpoints for approval of new drug applications

The US Food and Drug Administration (FDA) on Wednesday published a list of surrogate endpoints to help inform drug developer discussions with relevant Center for Biologics Evaluation and Research (CBER) or Center for Drug Evaluation and Research (CDER) review divisions.

The list, which was created thanks to the 21st Century Cures Act, includes surrogate endpoints that sponsors have used as primary efficacy clinical trial endpoints for approval of new drug applications (NDAs) or biologics license applications (BLAs). It also includes surrogate endpoints that may be appropriate for use as primary efficacy clinical trial endpoints for drug or biologic approvals, although they have not yet been used to support an approved NDA or BLA.

The list, which will be updated every six months, features surrogate endpoints for numerous diseases including acromegaly, different cancers, chronic kidney disease, cystic fibrosis, hepatitis A, B and C, HIV, hypertension and osteoporosis, among others.

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