The 'Dead Cat' Strikes Back: What Does US FDA Do With A Challenging Panel Outcome?

25 May 2018

• By Ramsey Baghdadi

Akcea’s volanesorsen for familial chylomicronemia syndrome barely made it through advisory committee due to a rare but unpredictable and rapidly presenting adverse event that likely can’t be resolved with a REMS. Now what?

Young kitten jumps and glide through the air

Many years ago, around the time when the US FDA was considering a “reevaluation” of the erythropoiesis-stimulating agents (ESAs) with a forthcoming advisory committee, the agency's dean of drug development Bob Temple was asked how the agency prepared for a panel meeting.

“I participate in a lot of these advisory committees," Temple said. "You have got to be careful. You don't want...