A new analysis finds that so-called first-cycle approval rates for new drugs, particularly for those that are given priority status, are slipping. And there is also a significant and ongoing decline in so-called priority designation rates.
Overall, there was a 25 percent decline in first-cycle approval rates for priority-rated new drugs and a 17 percent decrease in priority designations for new drug applications, or NDAs. First-cycle reviews for priority NDAs were 47 percent in fiscal year 2003 and continued to climb to 70 percent in fiscal year 2007, but have since slipped back to 53 percent in fiscal year 2009. Among standard NDAs, however, the rate has bounced around 40 percent, give or take a couple of percentage points during the same period. And for NDAs overall, the rate was 42 percent in fiscal year 2009, the lowest in four years.
These trends can be attributed to the FDA’s Safety First Initiative as well as the demands late in the NDA review process caused by a growing number of risk management strategies known as REMS.
As for priority designations for original NDAs, fiscal year 2005 marked a high of 30 percent after running as low as 10 percent four years earlier. However, that fell back to 13 percent in fiscal year 2009. Sources says the decline has been “most stunning” in for antiviral and oncology NDAs, which are the two therapeutic areas that have driven overall rates at the FDA’s Center for Drug Evaluation and Research in previous years. Priority designation rates for cancer NDAs have been declining consistently for several years, from 65 percent of the NDAs submitted between fiscal year 2003 and fiscal year 2005, to 18 percent in fiscal year 2009. The decline in AIDS and other antiviral therapies fell from 95 percent in fiscal year 2006 and fiscal year 2007 timeframe to just 8 percent among NDAs submitted in fiscal year 2009.