Opinion

Armen Asatryan: “Accelerated Approval”. This is, in my experience, probably one of the biggest misnomers in the United States pharma regulatory world.

Photo from Armen Asatryan/LinkedIn

Aug 19, 2023, 19:19

Armen Asatryan: “Accelerated Approval”. This is, in my experience, probably one of the biggest misnomers in the United States pharma regulatory world.

Quoting Armen Asatryan, Founder & CEO, iClinDev Consulting on LinkedIn:

” ‘Accelerated Approval’. This is, in my experience, probably one of the biggest misnomers in the US pharma regulatory world as there is neither “accelerated” nor “approval” in this concept per se. Let me explain. “Accelerated Approval” (AA) merely means that instead of 21 CFR 314-conforming endpoint of “feel, function, survive” (FFS), also know as a clinical endpoint, FDA will allow use of another type of endpoint — frequently called surrogate (a biomarker can be an example; see full list of these here: https://lnkd.in/gB2KKxXp) — in pivotal/Phase 3 trials. Presumably (and hopefully), this surrogate endpoint can be assessed in the trial earlier than the FFS endpoint (this is the purported “acceleration”), but then again, another trial (post-approval) with the FFS endpoint must be conducted — and won — or else FDA will rescind the “approval”; look at the list of withdrawn AAs here: https://lnkd.in/gtPc9sp7. Hence, AA is technically also a conditional approval, but that part does not get the attention it deserves as it takes long time for companies to do the confirmatory trial(s): I guess, partly because there is no real incentive and also because remember that an FFS endpoint can take a really long time to materialize. So, what could have been a better term? So far, I am coming up with not so marketable, but I think to the point, phrase: ‘non-clinical endpoint-based conditional pathway’.”

Source: Armen Asatryan/LinkedIn