Are The 90s Back? Oncologics Drove FDA’s 2012 Novel Approval Count To 15-Year High
This article was originally published in Pharmaceutical Approvals Monthly
With 45 new molecular entities and novel biologics cleared in 2012, FDA approvals have reached a level not seen since the mid-1990s, the golden age of modern medicine. The group reflects a boom in oncology; other drug development trends like orphan diseases and personalized medicine held steady. Big pharma contributed just over a third of the 2012 class, with Pfizer regaining the lead with five novel approvals.
You may also be interested in...
Even with half of CDER’s approvals qualifying for longer review timeframes under “the program,” the average time from submission to approval continued its multi-year decline, helped by a record high level of first-cycle approvals. Small molecules and big pharma dominated the 2013 class.
An FDA study evaluating NMEs by level of innovation finds level first-in-class approvals to be consistent, and approvals after the study period reinforce “encouraging” findings. Analysis says new metric should be basis for assessment of programs created by FDASIA to speed development of innovative products.
With 19 novel agents approved so far in 2013 and a full slate of candidates under review, the recovery in novel agent approvals after the doldrums of the 2000s is likely to continue even if the agency falls short of last year’s 45 approvals. Watch for action on the first “breakthrough” therapies submitted and advances in hepatitis C treatment.