Posted by Michael Wonder on 18 Aug 2019
EMA and FDA historically agree on just about every new drug approval, but is that slowly changing?
16 August 2019 - The EMA and US FDA concur more than 90% of the time in their decisions to approve new drugs, according to a new study from EMA and FDA officials that looked at 107 applications from 2014 to 2016.
In just eight of the 107 applications, FDA initially declined to approve a new drug or biologic while EMA approved it, although in all eight of those cases, FDA ended up approving that drug or biologic. And in one case (Takeda’s Ninlaro (ixazomib) for multiple myeloma), FDA approved the treatment and EMA initially did not, but later did.
“Overall, taking account of the resubmitted and reexamined applications, the EMA and the FDA had final discordant marketing authorization decisions for two drugs: corifollitropin alfa and ataluren,” the study notes, as both were approved by EMA and not FDA.
