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Post# of 19309
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DewDiligence

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DewDiligence

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Re: None

Saturday, 11/25/2006 6:21:14 PM

Saturday, November 25, 2006 6:21:14 PM

Post# of 19309
Challenges in the Therapeutic Use of
a So-Called Universal Hemostatic Agent:
Recombinant Factor VIIa

[Note the explicit mention of cost in the final paragraph, which underpins the business proposition that GTC and LFB are undertaking in challenging the hegemony of NovoSeven.]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&l...

>>
Hematology Am Soc Hematol Educ Program. 2006;:426-31.

Hoots WK.

Recombinant factor VIIa (rFVIIa) was developed in the early 1990s to provide "bypassing" hemostatic therapy for hemophilia A and B patients with inhibitors. More recently, it has been licensed for use in patients with inherited deficiency of factor VII.

Since it was licensed for use in hemophilia with inhibitors in the US, Europe, and other countries for these specific indications, it has been used selectively but in a wide array of clinical settings for uncontrolled hemorrhage in individuals without an inherited bleeding disorder. Many of these uses have been described in the medical literature as case reports or small, uncontrolled series. Several randomized clinical trials (RCT) for these "off-label" medical uses have been published in recent months and will serve as the focus of this review.

In particular, a review of an RCT for spontaneous intracranial hemorrhage that has demonstrated clinical efficacy in reducing both mortality and volume of central nervous system hemorrhage will be offered. A brief discussion of hypothesized physiologic mechanisms of supraphysiologic doses of rFVIIa will introduce the clinical discussion of these broad off-label uses.

Since rFVIIa is a very expensive therapy, possible strategies for optimizing its use in the these settings will be presented.
<<

“The efficient-market hypothesis may be
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