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Are The 90s Back? Oncologics Drove FDA’s 2012 Novel Approval Count To 15-Year High

 
• By Bridget Silverman

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.

Cancer therapies were the driving engine as FDA’s annual new molecular and biological entity approval count roared back to levels not seen since the boom years of the mid-1990s. Almost 40% of the 39 novel products approved by Center for Drug Evaluation and Research in 2012 went through the Office of Hematology and Oncology Products.

The CDER class of 2012 is 30% larger than 2011’s 30 novel approvals – and 2011 was a good year, a recovery from a seven-year NME doldrums where output averaged just under 22 novel approvals per year Also see "

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