Earlier this week, we delved into the topic of Accelerated Approval Pathways and the critical role played by surrogate endpoints. Today, let’s delve even deeper and explore the Table of Surrogate Endpoints—yes, such a table actually exists.
The 21st Century Cures Act mandated that the FDA publish a list of “surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or biological product” under both accelerated and traditional [FDA] approval provisions. The article today helps to point out the key considerations behind surrogate end points and how they may / must be used on a case-by-case basis. It also points out that a surrogate end point used in a failed drug application would be removed from the Table.
The FDA recognizes the limitations of the Table. In fact the FDA encourages developers to present novel end points for consideration and approval.
You can explore the table provided in the link below, which offers a detailed breakdown of endpoints categorized by specific diseases or uses, patient populations, types of approval, and even mechanisms of action. However, be advised that the Table may seem overwhelming due to its extensive information.
Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure
CLICK HERE to access the Table
