Oncologics Drove FDA’s 2012 Novel Approval Count To 15-Year High
With 45 new molecular entities and novel biologics cleared in 2012, FDA approvals have reached a level not seen since the mid-90s, 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.
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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.
FDA official says the rate of approving applications in the first review cycle may not increase much more, even as the new review model, intended to promote more first-cycle approvals, has yet to finish with its inaugural applications.
Twenty sponsors now have applications in the new review model, but none have reached the approval decision stage; industry officials say it still is too early to draw conclusions.