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Re: DewDiligence post# 6356

Sunday, 01/02/2005 9:06:58 PM

Sunday, January 02, 2005 9:06:58 PM

Post# of 257268
More on GTCB’s ATryn:

[This is a reply to #16938 on the Yahoo GTCB board. For some reason I am currently unable to post on Yahoo.]

>>…have you looked into the side effect profile of plasma-derived antithrombin in the HD indication to get an idea how well ATryn will stack up against it?<<

There are no head-to-head studies using the same patient pool, but GTCB has asserted that, based on published data, ATryn’s safety is comparable to that of plasma-based AT. We will soon find out if the EMEA agrees.

In the data package submitted to the EMEA, ATryn’s rate of DVT episodes was no higher than the typical rate for plasma-based AT. (Terminology note: because ATryn and plasma-based AT are given in order to reduce the risk of DVT, the DVT data really belong in the realm of efficacy rather than safety.)

There is no compelling reason to think that ATryn would be less safe than plasma-based AT. ATryn may turn out to be safer than plasma-based AT if there is a reduced risk of infection from blood-borne pathigens.

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