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NEWS & ANALYSIS
2015 FDA drug approvals
FDA approval rate continues to surge, with 45 green lights for new drugs granted in 2015.
Asher Mullard
Industry and the FDA have had backtoback landmark approval years. The agencys Center for Drug Evaluation and Research (CDER), which oversees the approval of small molecules and antibodies, approved 45 new drugs in 2015. This marksa 19year high, and is up from the previous recent record of 41 drugs in 2014 (FIG.1; TABLE1). It is also more than double the approval rate during 20052009, when approvals were at their lowest with an average of 22 drugs per year.
The 2015 cohort carries solid although not stellar commercial potential. Boston Consulting Group (BCG)s annual analysis ofa basket of new therapeutic drugs from the CDER and the Center for Biologics Evaluation and Research (CBER; TABLE2) found that the
average peak sales forecast for a 2015 approval is US$900 million. This is down from an average of $1.4 billion in 2014, when the FDA approved Gileads recordselling hepatitis C virus combination therapy Harvoni and two highly anticipated cancer immunotherapies (http://www.nature.com/nrd/journal/v14/n2/full/nrd4545.html
Web End =Nat. Rev. Drug Discov. 14, 7781; http://www.nature.com/nrd/journal/v14/n2/full/nrd4545.html
Web End =2015 ). It is 50% higher than the average sales value of the 2009 doldrums (FIG.2).
It was another great year, says Michael Ringel, senior partner at BCG. This is just a tremendous upward trajectory from the lowsof 2009. We think it is real, both in terms of the increase in the number of new therapeutic drugs and the recovery of peak sales, he adds.
Sixteen of the new CDER approvals (36% of the cohort) are expected to achieve blockbuster status (FIG.3).
By the numbers
By therapeutic area, cancer drugs continue to dominate the CDER approval list (FIG.4). The FDA approved 14 (31%) cancer drugs in 2015. Oncology has accounted for over 30% of the approvals for 3 of the past 4years (the exception was 2014, when it accounted for only 22% of approvals). Multiple myeloma did particularly well, with four new drug approvals last year, including the first two antibody therapies for this indication (http://www.nature.com/nrd/journal/v15/n1/full/nrd.2015.39.html
Web End =Nat. Rev. http://www.nature.com/nrd/journal/v15/n1/full/nrd.2015.39.html
Web End =Drug Discov. 15, 56; 2016 ). The CBER also approved Amgens talimogene laherparepvec, the first cancerkilling virus to...