How High Will the Number of FDA Approvals Go?

The FDA approved 46 novel drugs in 2017. This made news, since it was the highest number of drugs approved in a year since 1996. The FDA surpassed the 2017 total in October 2018, with 47 drugs being approved since the beginning of the year. In November 2018, eight more drugs were approved, raising the 2018 total to 55. This surpassed the all-time high of 53 novel drug approvals established in 1996.  

Over three-quarters of the drugs had priority review status.  All 55 drugs met their PDUFA goal date and 39 were approved in the US before other countries. If the FDA stays with the average of 5 approvals per month, it will reach 60 by the end of the year. 

Leading the way in approvals this year have been 32 orphan drugs, those budget buster specialty pharmacy products that play havoc with our drug spend. 2018 is the first year that more than half of the approved new drugs had orphan indications. It is interesting to note that the number of orphan drugs approved is more than the total number of drugs approved in three of the past seven years.

The Prescribe Right Pharmaceutical Pipeline Tracker is tracking three drugs with PDUFA dates at the end of December:

• The FDA approved prucalopride (Motegrity from J&J and Shire) on 12/17/18 for the treatment of adults with chronic idiopathic constipation. This brought the 2018 total to 56.
• Jazz Pharmaceutical’s solriamfetol has a December 20 PDUFA and is begin developed for the treatment of narcolepsy and excessive sleepiness in patients with obstructive sleep apnea.
• ​Servier’s calaspargase pegol has a December 22 PDUFA date and is seeking approval for the treatment of acute lymphoblastic leukemia (ALL).​

Stay tuned to our weekly updates for additional developments. In the meantime, check out the following links: 

See how you can easily track investigational drugs with priority review status.  
 
Check out how the Pharmaceutical Pipeline Tracker can provide valuable clinical formulary decision support for Specialty Pharmacists.