2015 was a banner year for drug approvals, with the FDA green-lighting 45 novel drugs. 2016, by comparison, appears to be a sizeable step backward, winning just 22 approvals from the US FDA. This drop cannot be explained by the number of novel drug filings which remained relatively stable at an estimated 41 in 2016 compared with an average of 36 in the period from 2007 to 2015.
Two principal reasons have been cited for the sharp decline:
- Five approvals planned for 2016 were completed ahead of schedule and contributed to 2015’s near-record high.
- Compared to previous years, the FDA issued a higher number of Complete Response letters in 2016. These letters describe deficiencies in the application, precluding approval, with advice on what the sponsor needs to do for FDA to support resubmission of the application. Interestingly, manufacturing issues accounted for a higher than expected number of these letters being raised.
On a more positive note, a high number of the approvals in 2016 were innovative drugs addressing an unmet medical need.
- 41% of the approvals were for treatment of a rare or ‘orphan’ disease.
- 36% of the approvals were First-in Class drugs meaning their mechanism of action differed from existing therapies.
- Oncology diagnostic agents or therapies represented the largest single therapeutic area comprising over 20% of approvals.
As a consequence, a high number of therapies received an expediated approval process so patients could benefit from these innovative therapies: 36% were fast tracked, 32% were break-through therapies (providing substantial improvement over available therapies), 68% received priority review (reviewed in 6 months rather than 10) and 27% received accelerated approval (for serious or life threatening conditions).
It could be argued that quality is more important that quantity and in this respect 2016 did not disappoint. Figures for 2017 may be difficult to predict based on the past couple of years and it will be interesting to understand if 2016 is just a blip in the number of approvals or if it represents the beginning of a downward trend.