EMA and FDA historically agree on just about every new drug approval, but is that slowly changing?
The EMA and 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, the FDA initially declined to approve a new drug or biologic while the EMA approved it, although in all eight of those cases, the FDA ended up approving that drug or biologic. And in one case (Takeda’s Ninlaro (ixazomib) for multiple myeloma), the FDA approved the treatment and the EMA initially did not, but later did.
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