Makena shows why FDA wants confirmatory trials started before accelerated approval

Preterm birth drug Makena’s turbulent 12 years from accelerated approval to pending removal from the market showcase how long it can take to obtain confirmatory evidence of clinical effectiveness, as well as how cumbersome the process is for forcing an ineffective drug off the market. Cases such as Makena have driven Congress and FDA to require confirmatory trials to be under way at the time accelerated approval is granted.

Late Tuesday, Covis Pharma S.a.r.l. said it was seeking the withdrawal of the synthetic version of naturally occurring 17 α-hydroxyprogesterone caproate (17P), which was first approved in 2011 and has since generated more than $1.5 billion in sales. ...