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

Judit Rius Sanjuan judit.rius at keionline.org
Wed Aug 25 08:06:26 PDT 2010

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On Aug 25, 2010, at 9:34 AM, James Love wrote:

> 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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Judit Rius Sanjuan
Knowledge Ecology International (KEI)
NYC Phone: 212 222 5180
Washington DC Phone: 202 332 2670

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