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The FDA new drug approvals of 2009
Welcome to our look back at the new drug approvals of 2009. Last year the FDA gave the green light to an impressive 26 new therapies, slightly beating the 2008 total of 25. Of those, seven were newly-approved biologics, leading analysts to wonder whether 2009 was the year the biotech industry finally came into its own. The biggest NME winner was Novartis, which boasted four new approvals. The company was followed by Johnson & Johnson's Centocor Ortho Biotech and GlaxoSmithKline, with two approvals apiece.
Below is the list new drugs in order of date approved. Like other news outlets, FierceBiotech relied on the list of CDER approvals (not CBER approvals) provided by the FDA to compile this feature. Click here to begin the slideshow ⇒
Comments
Note, this review of 2009 "new drug" approvals is flawed (without knowing its severe limitation)! This article omits most new therapeutics approved as biologics (by CBER). The statement that 7 biologics were approved in 2009 is way off.
Original, full approvals (all regulated as biologics except for Creon) not included in this article include:
1) Wilate (Factor VIII:vWF from Octapharma)
2) Agriflu (influenza vaccine from Novartis)
3) Cervarix (recombinant HPV vaccine from GSK)
4) Berinert P (C1-esterase inhibitor from CSL)
5) Gammaplex (IgG from Bio Products Lab.
6) Hiberex (Haemophilus b Vaccine from GSK)
7) Creon (pancrealipase from Solvay)
8) Ixiaro (Japanese Encephalitis Vaccine from Intercell)
9) Atryn (recombinant antithrombin-III from Genzyme Transgenics)
10) RiaSTAT (fibrinogen from CSL)
Note, excluded products included the first transgenic animal (goat)-expressed recombinant protein (Atryn) and the first insect cell (baculovirus vector)-expressed product (Cervarix HPV vaccine). So, this article's list does not even include major new precedent-setting recombinant protein approvals.
Otherwise, Extavia (interferon beta) from Novartis is not a new product. Yes, it received a new, full BLA, but it is simply Betaseron from Bayer Schering relabeled by the company for sale by Novartis.
For a full list of 2009 FDA biopharmaceutical approvals and related analysis that I authored, see www.biopharma.com/approvals_2009.html; and for a running list of approvals, see www.biopharma.com/approvals.html.
The primary source for the flawed data used in this article is apparently a recent study, also reported in Fierce publications, by Mr. Loss, Washington Analysis. In speaking with Mr. Loss, he confirmed that his study only included products approved by the drugs (CDER) division of FDA, while totally ignoring original, full approvals (BLAs) granted by the biologics (CBER) division of FDA. His analyses over the years are consistent, in the sense that he has consistently ignored biologics div. approvals. But to make claims about the number of total new pharmaceuticals and new biopharmaceuticals/biologics approved in 2009 based on this data is simply wrong.
Thanks you for your comment. We did rely on the CDER and not the CBER data to compile this list. However, Fierce is verifying the FDA approvals and will update readers on what we find. If necessarily, we will run a separate feature addressing 2009 CBER approvals.
Fine information, many thanks to the author. It is puzzling to me now, but in general, the usefulness and significance is overwhelming. Very much thanks again and good luck!
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