[Ip-health] Notes on the 2004 to 2009 United States Food and Drug Administration Approval of New Molecular Entities (NMEs)

James Love james.love at keionline.org
Wed Aug 25 06:34:46 PDT 2010


Molly Redfield Ward has written a research note looking at six years of
new molecular entities approved by the FDA. Ms Ward's research is
descriptive, focusing on such characteristics as the FDA classifications
for new NMEs (in terms of priority or orphan status), the disease or
function that the NMEs will address, the WHO Type I,II and III
classification.

Among the many interesting findings from her note are these:

* Including both NDAs (pharmaceuticals) and BLAs (biologics) there were
145 NMEs over the 6 year period. 
* 15 percent of NMEs were classified as biologic products.
* 30 percent of all NMEs were classified as orphan products.
* Roughly half of NME priority products were also classified as orphans.
* 80 percent of all orphan products were classified as priorities.
* 73 percent of biologic products received priority status. 
* 45 percent of biologic products were considered orphan products.  
* Cancer was by far the largest category of disease for NMEs, with 24
NMEs.
* Products for heart disease and psychological (excluding addiction)
were the 2nd largest group, each with 11 NMEs.
* None of the products for psychological, diabetes, diuretics, over
active bladder or respiratory illnesses received a priority review
status.
* 79 percent of cancer products, and 100 percent of products for AIDS
and six other disease or function categories received priority status.
* When looking at the WHO criteria for incidence of disease by incomes,
there were 139 Type I products approved, 6 Type II products, and no Type
III products approved, over the six year period. 

The research note is available in PDF or HTML format here:
	
http://keionline.org/rn2010-3

Notes on the 2004 to 2009 United States Food and Drug Administration
Approval of New Molecular Entities (NMEs)






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