Reuters has reported that the FDA greenlighted a total of 46 new therapies in 2017, the highest tally in 21 years and more than double the total in 2016. Some of this has to do with the timing of data, and the completion of trials, and the priority review process.
It is interesting to note that 2017’s total was actually 49 if cell therapies from Novartis (KYMRIAH) and Gilead Sciences (YESCARTA) and Spark Therapeutics’ gene therapy LUXTURNA are included (all were approved under a different category than medicines).
Alluded to above, there were data timing issues but the primary reason for the high number of approvals was the FDA’s accelerated review process for selected drugs.
The number getting the greenlight this year may moderate a bit since several approvals expected this quarter were granted in Q4 2017.
Many eyes are on Europe since the European Medicines Agency (EMA) will be moving to Amsterdam from London this year which may disrupt/delay approvals there.
In 2017, the EMA backed 92 new drugs, including generics, up 12% from 2016’s total of 81.
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