Accelerated Approval

What is accelerated approval?

An FDA instituted program that allows for earlier approval of drugs that treat serious or life-threatening conditions and fill an unmet medical. Accelerated approvals rely on the measurement of surrogate endpoints as a measure of clinical benefit to the patients. Drugs that meet the standard for traditional approval are not eligible for accelerated approval.

When is accelerated approval used?

Accelerated approval is used when a disease course is long and measuring the clinical benefit would require significant time. Examples are drugs used to treat certain cancers or HIV infection where an effect on tumor growth or viral load can be demonstrated quickly but the effect on survival is long-term because of the typical disease course.

Another scenario in which accelerated approval is used are acute diseases where a large study would be needed to show clinical benefit because of the rarity of the event but a surrogate endpoint is available that can be used in a much smaller and therefore faster study.