Posted 12 April 2017
By Michael Mezher
The US Food and Drug Administration (FDA) is poised to make a comeback from the relatively low number of new drugs approved in 2016, though it's unlikely to match the approval highs from 2014 and 2015.
Already in 2017, FDA has approved 14 new drugs, though that quick pace is not likely to continue and the rest of the year is shaping up to be an average or slightly above average year for approvals.
Based on data from BioPharmCatalyst, FDA has just over 20 remaining applications for new drugs and biologics with review goal dates in 2017 and FDA is unlikely to approve much more than 30 new drugs in 2017.
If FDA were to approve three-quarters of those with PDUFA goal dates in 2017, that would put the agency at around 30 new drugs approved for the year, just over its ten-year average of 29.3 new drugs approved per year.
|New Molecular Entities and Novel New BLAs With 2017 Goal Dates|
|Baricitinib||Incyte, Eli Lilly|
|Brineura (Cerliponase Alfa) ||Biomarin |
|Evenity (romosozumab)||Amgen, UCB|
|Vesneo (Latanoprostene bunod)||Valeant|
|Enasidenib||Celgene, Agios |
|Sirukumab||Johnson & Johnson, GlaxoSmithKline|
|Guselkumab ||Johnson & Johnson|
|Ertugliflozin ||Merck, Pfizer|
In 2016, FDA approved only 22 new molecular entities (NMEs) and novel new biologics license applications (BLAs), its fewest since 2010 and down considerably from its recent highs in 2014 and 2015.
And while FDA's former Office of New Drugs Director John Jenkins attributed the decline in part due to fewer applications from industry, more rejections and a handful of drugs approved in 2015 ahead of their 2016 goal dates, many questioned whether 2016 was a sign of a slowdown at the agency.